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Studies Open to Enrollment

Heart Failure with Preserved Ejection Fraction

Left Ventricular Aneurysm

Study Name: ALIVE

Study Objective: To evaluate safety/efficacy of a new device, called the BioVentrix Revivent TC System, designed to treat LVA.

Key Inclusion Criteria:

  • Age 18 – 80
  •  LVEF < 45%
  • NYHA Class > 2 not responsive to medical therapy
  •  LV Aneurysm/Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) scar
  • LV Aneurysm/Scar Location: Defined as a scar involving septum and anterior, apical or anterolateral regions of the left ventricle as evidenced by cardiac imaging and referred for surgical management

Key Exclusion Criteria:

  1. Cardiac Resynchronization Therapy (CRT) device placement ≤ 60 days prior to enrollment;
  2. Peak Systolic Pulmonary Arterial Pressure > 60 mm Hg via echo or RHC and/or evidence of cor pulmonale
  3. Within the last six months, a prior CVA or TIA, or any intracranial hemorrhage, or any permanent neurologic deficit, or any known intracranial pathology
  4. Chronic renal failure with a serum creatinine >2.5 mg/dL and/or GFR<30ml/min

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POST MI/HFrEF

Study Name: BioCardia

Study Objective: To evaluate safety/efficacy of CardiAMP cell therapy system in patients with post MI HF.

Key Inclusion Criteria:

  • Previous MI (> 6 months)  
  • EF ≥ 20% and ≤ 40% by echo
  • On stable evidence-based medical and device therapy for HF or post-infarction left ventricular dysfunction

Key Exclusion Criteria:

  • GFR < 30
  • Have a mechanical aortic valve or heart  constrictive device
  • AS or AI > 2+
  • CHB or QTc interval >550 ms                          

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AMYLOID

Study Name: ION-682884-CS2 (Amyloid)

Study Objective: A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled

Study to Evaluate the Efficacy and Safety of ION-682884 in Patients with Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM)

Key Inclusion Criteria:

  • Medical history of HF secondary to hereditary or wild-type ATTR-CM with at least:

A) prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker/ICD (implantable cardioverter defibrillator) placement, OR

B) symptoms and signs of volume overload or elevated intracardiac pressure that either requires or required treatment with diuretics for clinical stabilization

  • End-diastolic interventricular septum thickness of > 12 mm on screening echocardiogram
  • Screening NT-proBNP ≥ 600 pg/mL by central lab. 4. New York Heart Association (NYHA) class I-III
  • 6MWT ≥ 150 meters

 Key Exclusion Criteria:

  • Hospitalization or urgent visit to ER/ED for worsening of HF with discharge date within

4 weeks prior to or during Screening

  • Uncontrolled hypertension SBP > 160 or  DBP > 100 mmHg
  • Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated  liver transplant or LVAD within 1 year after randomization
  •  Active infection requiring systemic antiviral or antimicrobial therapy that will not be   

               completed prior to Study Day 1

  • Known history of or positive test for human immunodeficiency virus (HIV)

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Study Name: RELIEVE-HF

Study Objective: To evaluate safety/efficacy of the V-Wave Interatrial Shunt System to improve clinical outcomes in a certain high-risk subset of symptomatic patients suffering from HF.

Key Inclusion Criteria:

 1. Ischemic or non-ischemic cardiomyopathy

2. NYHA Class III or amb Class IV HF

3. Receiving guideline directed medical therapy

4. Prior HF Hosp >24 hours or ER HF Visit with duration ≥6 hours, or HF Clinic ADHF Visit with

     duration ≥6 hours, within 12 months

5. 6MWT ≥100 meters and ≤450 meters

 Key Exclusion Criteria:

1. BMI >45 4. Resting SBP <90 or >160 mmHg

2. PA systolic pressure >70 mmHg

3. (LVEDD) >8cm

4. Mod-sev MS or AS

5. Acute MI, ACS, PCI, or other major surgery within 3 months of baseline visit

6. Stroke, TIA, DVT within 6 months of baseline visit

 

Study Contacts: PI: Maria Karas, MD (646) 962 5555

                           RC:  Katelyn Bastert,   (212) 746 2698 

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Aortic Stenosis

IRB Protocol #: 1701017892

Overview: To assess whether TAVR should be performed on patients who have been diagnosed with aortic stenosis, but have not yet developed symptoms. Patients who do not have symptoms will either undergo TAVR or be closely monitored with medical therapy.

Patients must:

  • Be older than 65
  • Have severe aortic stenosis
  • Have a negative treadmill stress test
  • Be informed of the nature of the study, agree to its provisions, and provide written informed consent as approved by the institutional review board of the clinical site 

Patients cannot participate if:

  • Symptomatic
  • Have any concomitant valvular, aortic, coronary artery disease requiring surgery making AVR a Class I indication
  • Have a pre-existing mechanical or bioprosthetic valve in any position
  • Have significant abdominal or thoracic aortic disease (such as aneurysm, severe calcification, aortic coarctation, etc.)

Early TAVR Trial: Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients with AsYmptomatic Severe Aortic Stenosis

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IRB Protocol #: 1601016864

Overview: To assess safety and efficacy of the Portico Valve in patients who are high or extreme risk for open heart surgery.

Patients must be:

 •      Assessed by surgeons and deemed either high or extreme risk for open heart surgery

 •      Severe, symptomatic aortic stenosis

 •      The subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB) of the respective clinical site

Patients cannot participate if they have:

 •      Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation 3-4+)

 •      Pre-existing prosthetic heart valve or other implant in any valve position, prosthetic ring, severe circumferential mitral annular calcification (MAC) which is continuous with calcium in the LVOT, severe (greater than 3+) mitral insufficiency, or severe mitral stenosis with pulmonary compromise. Subjects with pre-existing surgical bioprosthetic aortic heart valve should be considered for the Valve-in-Valve registry

 •      Life expectancy <12 months from the time of informed consent due to non-cardiac co-morbid condition 

PorticoTM Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO)

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Cardiac Resynchronization Therapy for Non-Responders

IRB Protocol #: 1703018038

Overview: The purpose of this study is to discover genetic factors that may cause idiopathic PVCs or VT. Previous studies have found some abnormal genes in the heart muscle cells of patients with idiopathic PVCs or VT, but currently it is not known exactly which abnormal genes cause idiopathic PVCs or VT, or how they create the conditions in the heart muscle cells that lead to this condition. The findings of this study may help us understand how this cardiac condition comes about, and may ultimately lead to new treatments for this (and possibly other) heart rhythm disorders.

Premature ventricular contractions (PVCs), a condition in which extra, abnormal heartbeats beginning in one of your heart's lower chambers (ventricles) disrupt your regular heart rhythm. Because the cause of your PVCs cannot be determined, the term “idiopathic” is used to describe them. If PVCs occur for 3 or more consecutive heartbeats, they are considered to be a case of ventricular tachycardia (VT), a type of heart rhythm disorder in which the ventricles beat too quickly.

This trial is not funded.

To be eligible, patients must:  

  • Be greater than 18
  • Have been diagnosed with idiopathic PVCs or VT

Patients cannot participate if they have:

  • Not been diagnosed with idiopathic PVCs or VT

Gene Analysis of Idiopathic Ventricular Tachycardia

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IRB Protocol #: 1708018442

Overview: The purpose of the study is to test a new way to pace the left side of the heart without using pacing leads, using the WiCS-LV System. A cardiac (heart) resynchronization therapy (CRT), is a device that regulates your heartbeat. A new type of system, called the WiCS-LV System, is a wireless cardiac stimulation system for the left ventricle intended to help reduce certain complications associated with traditional CRT devices. CRT therapy has been previously either been recommended, or has been implanted without improving your condition, or has been attempted to be implanted without success. It has not been approved for general use by the Food and Drug Administration (FDA), and its use in this study is considered investigational. 

In this study, ultrasound will be used to transfer energy from a new type of pacemaker through your body to a special receiver that is placed inside the left ventricle of your heart.  The receiver will use the ultrasound energy to pace the heart without using pacing leads.

This trial is funded by EBR Systems.

To be eligible, patients must:  

  • Be greater than 18
  • Have been diagnosed with class I or IIa indication for an implantation of a CRT-D device and have been diagnosed as a non-responder. Have a CRT system and attempts at optimal device programming that has not responded for a minimum of 6 months
  • Have been diagnosed as untreatable with a full or partial CRT system implanted
  • Must be in sinus rhythm

Patients cannot participate if they have:

  • Been diagnosed with right bundle branch block (RBBB)
  • Been diagnosed with NYHA class IV
  • Been diagnosed with contraindication to heparin, chronic anticoagulants or antiplatelet agents
  • Chronic dialysis
  • Been implanted with mechanical aortic valves or TAVR valves
  • Been diagnosed with persistent or permanent atrial arrhythmias or have received a cardioversion for atrial fibrillation within the past month
  • A drug or alcohol addiction

NCT02922036

SOLVE CRT Study: Stimulation Of the Left Ventricular Endocardium for Cardiac Resynchronization Therapy (CRT) in Non-Responders and Previously Untreatable Patients

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Pulmonary Hypertension

Study Name: ALIVE

Study Objective: Determine the effect of GB002 on improving   pulmonary hemodynamics in subjects with World Health Organization (WHO) Group   1 PAH who are WHO Functional Class (FC) II or III

 Key Inclusion Criteria:

  • current diagnosis of symptomatic PAH classified by one of the following:
  • a. Idiopathic PAH (IPAH) or heritable pulmonary arterial hypertension (HPAH).

b. PAH associated with one of the following connective tissue diseases (CTDs):

− Systemic sclerosis,

− Mixed CTD or overlap syndrome,

− Systemic lupus erythematosus.

c. PAH associated with anorexigen or methamphetamine use.

d. Congenital heart disease with simple systemic to pulmonary shunt at least 1 year

     after surgical repair.

  • 6MWD ≥ 150 meters and ≤ 550 meters at screening.
  • WHO FC II or III symptomatology.
  • RHC confirming PAH
  1. mPAP ≥ 25 mmHg (at rest),
  2. Pulmonary capillary wedge pressure ≤ 15 mmHg, or mean left atrial pressure (mLAP) or left ventricular-end diastolic pressure (LVEDP) ≤ 15 mmHg in the absence of left atrial obstruction,

c. PVR ≥ 400 dyne•s/cm5.

Key Exclusion Criteria:

  • Evidence of chronic thromboembolic disease or acute pulmonary embolism as assessed by ventilation-perfusion (V/Q) scan, computed tomography (CT)-angiogram, or pulmonary angiogram
  • SBP > 160 or SBP < 90
  • WHO Pulmonary Hypertension Group 2–5.
  • Untreated obstructive sleep apnea

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Study Name: Ralinepag 301

Study Objective: A Phase 3, randomized, double-blind, placebo-controlled study to

evaluate the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background oral therapy in subjects with World

Health Organization (WHO) Group 1 pulmonary hypertension (ADVANCE Outcomes)

Key Inclusion Criteria:

  • Primary diagnosis of symptomatic PAH, IPAH, HPAH
  • WHO/NYHA FC II to IV symptoms
  • RHC w/i 3 yrs or at screening

Key Exclusion Criteria:

3 or more of following:

  •  BMI ≥30
  • DM
  • HTN
  • CAD
  • Chronic AF

2. Evidence of > mild lung disease on PFT w/i 6M

3. Evidence of thromboembolic disease

4. Severe chronic liver disease

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Study Name: Ralinepag 302

Objective: The primary objective of this study is to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak VO2 derived from CPET after 28 weeks of treatment.

Inclusion criteria:

  1. Has had a diagnostic RHC performed within 1 year of Screening
  2. Has WHO/NYHA FC 2 to 3 symptoms.
  3. Must have initiated first PAH-specific oral therapy with an ERA and/or a PDE5-I or a sGC stimulator within 9 months prior to Screening and be on a stable dose(s) defined as no change in dose or regimen for at least 30 days prior to Screening.
  4.  Has a 6MWD of ≥150 meters at Screening.

Exclusion criteria:

  1. Current unstable angina
  2. Symptomatic coronary disease and/or myocardial infarction within past 6 months.
  3. Current symptomatic aortic or mitral valve disease.
  4. Current diagnosis of uncontrolled sleep apnea in the opinion of the Investigator.
  5. Requires use of supplemental oxygen during CPET.

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Study Name: Ralinepag 303

Study Objective: A Phase 3 open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in subjects with World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) (ADVANCE Extension)

Key Inclusion Criteria:

  1. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study.

Key Exclusion Criteria:

  1. Subjects who withdrew consent during participation in another ralinepag study.
  2.  Subjects who have undergone lung or heart/lung transplant or the initiation of long-term
  3. Parenteral (IV or SC infusion) or inhaled therapy with a prostacyclin or oral
  4. therapy with another IP receptor agonist during the time since participation in their
  • original ralinepag study.
  1. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

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Cardiac Arrhythmia

IRB Protocol#: 1612017824

ClinicalTrials.gov Identifier: NCT02637947

Overview: The purpose of this study is to compare two kinds of systems that are used to control the catheter during VT ablation: one that uses magnetic fields and one that uses a manual pull wire. Both kinds of systems are approved by the Food and Drug Administration (FDA), and both are regularly used by the cardiologists at WCMC/NYPH. The study is being done because it is not known whether one kind of system provides better results than the other.

This trial is funded by Stereotaxis.

To be eligible, patients must:

  • Be a candidate for VT ablation
  • Have failed at least one drug therapy in managing VT
  • Have an ICD previously implanted
  • Have had a myocardial infarction
  • Have a left ventricular ejection fraction (LVEF) less than or equal to 35%

Patients cannot participate if they have:

  • A history of stroke within 1 month prior to enrollment
  • Had an acute myocardial infarction within 30 days prior to enrollment
  • Undergone cardiac surgery within 60 days prior to enrollment
  • Had a previous pericarditis or cardiac tumor

MAGNETIC-VT: A prospective, multi-center, post market randomized controlled trial comparing VT ablation outcomes using remote MAGNETIC navigation guided substrate mapping and ablation versus manual approach in a low LVEF population

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IRB Protocol #: 1405015148

Overview: The purpose of the study is to test an algorithm or programming of the CRT system. It is a randomized study so you may be assigned (“randomized”) to one of two groups. You will either be in the “treatment” group which means your device will have the new aCRT feature turned on or be in the “control” group which means your CRT device will be programmed by whatever other method your study doctor chooses. A Cardiac Resynchronization Therapy (CRT) device system is a treatment for heart failure. It is an electronic medical device that is implanted in the body to provide electrical pacing to both of the lower chambers of the heart (ventricles), so they will beat at exactly the same time, or almost exactly, which can help your heart to pump blood to the body more efficiently. This kind of device includes a small computer which determines the pacing of the ventricles, as well as insulated wires or “leads” to connect the pacing device to the heart.

When a patient receives a CRT system, the timing of the pacing must be established. This is called “programming” the device. Currently, patients who receive a CRT system may have the device programmed with the standard settings installed by the manufacturer, or the settings may be adjusted by a cardiologist with the help of an echocardiogram (echo) or an electrocardiogram (ECG). The Medtronic devices being used in this study possess a feature called AdaptivCRT or aCRT. This feature detects patterns in the heart’s contractions and automatically adjusts the programming of the CRT device without using an echo or ECG. This feature has been approved for use by the Food and Drug Administration (FDA). The purpose of this study is to investigate whether aCRT provides better health outcomes than any of the other programming options available to the cardiologist for treatment of a person with a heart condition similar to yours.

In order to answer this question, half of the subjects enrolled in this study will receive a CRT device that is programmed by the aCRT feature. The other half of the subjects will receive a CRT device that is programmed by whatever other method the cardiologist would use, according to their best medical judgment, for a person who received this device but was not enrolled in the study. It is important to understand that, currently, cardiologists are not required to use the aCRT feature, or any other single method, to program CRT devices, because it is not known with certainty whether any one method is better than the others.

This trial is funded by Medtronic.

To be eligible, patients must:

  • Be greater than 18
  • Have been diagnosed with Left Bundle Branch Block (LBBB)

Patients cannot participate if they have:

  • Have been diagnosed with permanent atrial arrhythmias
  • Have received  a mechanical tricuspid heart valve

The AdaptResponse Study

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IRB Protocol #: 1609017561

Overview: The purpose of this study is to learn more about the underlying mechanism of the heart rhythm disorder, or “arrhythmia,” known as premature ventricular contractions (PVCs), by testing whether PVCs can be terminated by a cardiac medication known as adenosine. Previous studies have given us some reasons to believe that the answer is yes, but it is not known for sure. The findings of this study may help us understand how this cardiac condition comes about, and may ultimately lead to new treatments for it (and possibly other arrhythmias).

This trial is not funded.

Eligible patients must:

•          Be older than 18

•          Have frequent monomorphic PVCs

•          Be undergoing a catheter ablation

Patients cannot participate if:

•          Diagnosed with severe aortic stenosis

•          Diagnosed with structural heart disease

•          Currently being treated with antiarrhythmic drugs

•          Diagnosed with asthma

Use of Adenosine to Determine the Electrophysiological Mechanism of Premature Ventricular Contractions

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Heart Block (Bradycardia)

IRB Protocol #: 1207012716

Overview: The purpose of this registry is to collect information over time regarding the long term performance and use of Medtronic’s market-released products. This means that you have or will have a commercially available product that is approved for use by the US Food & Drug Administration (FDA).  It is required by the FDA to monitor how Medtronic’s medical devices are working.

This trial is funded by Medtronic.

To be eligible, patients must: 

  • Be greater than 18
  • Have been implanted with a Medtronic device

Patients cannot participate if they have:

  • Have not been implanted with a Medtronic device

NCT01524276

Medtronic Product Surveillance Registry

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IRB Protocol #: 1704018134

ClinicalTrials.gov Identifier: NCT02290028

Overview: The purpose of this study is to confirm the long-term safety of the BIOTRONIK Sentus QP lead used with the BIOTRONIK CRT-D device. These leads are legally marketed in the United States and not investigational products. The study involves collection and review of data at regular follow-up visits with your doctor.

This trial is funded by BIOTRONIK.

To be eligible, patients must:

  • Be a candidate for CRT-D
  • Be able and willing to complete all routine study visits at our site through five years of follow up
  • Accept Home Monitoring® concept

Patients cannot participate if they have:

  • A left ventricular lead already implanted or had prior attempt to place a left ventricular lead
  • A cardiac surgical procedure, such as coronary artery bypass graft or valve surgery that is planned to occur within 6 months after implant or ablation that is planned to occur within 90 days after implant
  • Another life-threatening, underlying illness separate from their cardiac disorder 

QP ExCELs: Sentus QP – Extended CRT Evaluation with Quadripolar Left Ventricular

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IRB Protocol #: 1704018115

ClinicalTrials.gov Identifier: NCT03170583

Overview: The purpose of this study is to evaluate the long term safety of the FDA approved St. Jude Medical Tendril MRI™ lead implanted with the Accent MRI™ pacemaker or similar model such as Assurity MRI™, Endurity MRI™, together known as the SJM Brady MRI system. Additionally, the study will look at how the SJM Brady MRI system works after it has undergone an MRI scan.

This trial is funded by St. Jude Medical.

To be eligible, patients must meet one of the following criteria:

  • Subject who will be implanted with at least one Tendril MRI™ lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model).
  • Subject who is implanted with at least one Tendril MRI lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model) and is being rolled over after being previously enrolled in the Accent MRI IDE study.
  • Subject who is implanted with at least one Tendril MRI lead with a MRI compatible pacemaker such as the Accent MRI™, Assurity MRI™, or Endurity MRI™ (or similar model) but is not enrolled in Accent MRI IDE study. 

Patients cannot participate if they have:

  • Been enrolled or intend to participate in another clinical trial
  • Another health condition that prevents them from completing all routine study visits

SJM Brady MRI Post Approval Study

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IRB Protocol #: 1405015148

Overview: The purpose of the study is to test an algorithm or programming of the CRT system. It is a randomized study so you may be assigned (“randomized”) to one of two groups. You will either be in the “treatment” group which means your device will have the new aCRT feature turned on or be in the “control” group which means your CRT device will be programmed by whatever other method your study doctor chooses. A Cardiac Resynchronization Therapy (CRT) device system is a treatment for heart failure. It is an electronic medical device that is implanted in the body to provide electrical pacing to both of the lower chambers of the heart (ventricles), so they will beat at exactly the same time, or almost exactly, which can help your heart to pump blood to the body more efficiently. This kind of device includes a small computer which determines the pacing of the ventricles, as well as insulated wires or “leads” to connect the pacing device to the heart.

When a patient receives a CRT system, the timing of the pacing must be established. This is called “programming” the device. Currently, patients who receive a CRT system may have the device programmed with the standard settings installed by the manufacturer, or the settings may be adjusted by a cardiologist with the help of an echocardiogram (echo) or an electrocardiogram (ECG). The Medtronic devices being used in this study possess a feature called AdaptivCRT or aCRT. This feature detects patterns in the heart’s contractions and automatically adjusts the programming of the CRT device without using an echo or ECG. This feature has been approved for use by the Food and Drug Administration (FDA). The purpose of this study is to investigate whether aCRT provides better health outcomes than any of the other programming options available to the cardiologist for treatment of a person with a heart condition similar to yours.

In order to answer this question, half of the subjects enrolled in this study will receive a CRT device that is programmed by the aCRT feature. The other half of the subjects will receive a CRT device that is programmed by whatever other method the cardiologist would use, according to their best medical judgment, for a person who received this device but was not enrolled in the study. It is important to understand that, currently, cardiologists are not required to use the aCRT feature, or any other single method, to program CRT devices, because it is not known with certainty whether any one method is better than the others.

This trial is funded by Medtronic.

To be eligible, patients must:

  • Be greater than 18
  • Have been diagnosed with Left Bundle Branch Block (LBBB)

Patients cannot participate if they have:

  • Have been diagnosed with permanent atrial arrhythmias
  • Have received  a mechanical tricuspid heart valve

The AdaptResponse Study

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Supraventricular Tachycardia (SVT)

IRB Protocol #: 1801018891

Overview: The purpose of this study is to collect data that may determine whether the study drug, an investigational drug known as etripamil nasal spray, is able to effectively stop an episode of PSVT when taken by a patient to self-treat their PSVT episode. Paroxysmal Supraventricular Tachycardia (PSVT) is an arrhythmia (or heart rhythm disorder) that results in sudden episodes of rapid heart rate, usually at a rate greater than 100 beats per minute. A normal heart rate is about 60 beats per minute. 

This trial is funded by Milestone Pharmaceuticals

To be eligible, patients must:

•   Be older than 18

•   Have been diagnosed with PSVT 

Patients cannot participate if:

•   Diagnosed with hypotension

•   Allergic to verapamil

•   Currently being treated with amiodarone

•   Have a history of severe ventricular arrhythmia

•   Have been diagnosed with congestive heart failure

•   Have suffered a stroke in the past 6 months

Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of Etripamil Nasal Spray for the Termination of Spontaneous Episodes of Paroxysmal Supraventricular Tachycardia: The NODE-301 Trial

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Coronary Artery Disease

Physiologic Assessment of Coronary Stenosis Following PCI (DEFINE PCI)

IRB Protocol #: 1703018095

Overview: The purpose of this  study is to collect data and assess measurements in your heart artery before and after your interventional procedure. Additionally the doctors will collect additional data to compare pressure wire measurements using the iFR pullback to the successful x-ray results after your interventional procedure. This trial is funded by Philips Volcano Corporation. 

Eligible patients must:

  • Be older than 18
  • Be diagnosed with coronary artery disease
  • Be an acceptable candidate for stenting
  • Be informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the clinical site

Patients cannot participate if they have:

  • Had a CABG
  • A low ejection Factor (EF)
  • A life expectancy of less than 12 months
  • An ongoing heart attack
  • An ongoing kidney disease

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IRB Protocol #: 1707018360

Overview: The purpose of this study is to test the Svelte Drug Eluting Coronary Stent by comparing it to any commercially  approved Abbott Vascular Xience or Boston Scientific Promus Drug Eluting Coronary Stent. The condition being studied is symptomatic ischemic heart disease, such as angina or a previous myocardial infarct, which is plaque formation in the arteries of your heart that requires treatment. This trial is funded by Svelte Medical Systems. 

Patients must:

  • Be older than 18
  • Be diagnosed with coronary artery disease
  • Be an acceptable candidate for stenting
  • Be informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the institutional review board of the clinical site

Patients cannot participate if:

  • Currently on blood thinners such as warfarin
  • Have an allergy to contrast that cannot be premedicated
  • Have an ongoing heart attack
  • Have ongoing liver or kidney disease

The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte DES-IDS and DES-RX Sirolimus-Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study 

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Arrythmia and Cardiac Electrophysiology

This research study is for men and women who are diagnosed with ventricular tachycardia suitable for ablation. The purpose of the study is to assess the utility of an imaging procedure known as contrast-enhanced intracardiac echocardiography (ICE) in this procedure.

Study subjects are enrolled for one or two days only.

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Interventional Cardiology and Valvular Heart Disease

This clinical trial is for men and women diagnosed with ischemic heart disease (myocardial ischemia) who are eligible to be treated with coronary angioplasty (PCI). Eligible patients include persons with angina (stable, unstable, or post-infarct), or silent ischemia.

The purpose of the study is to evaluate the safety and effectiveness of the Absorb Bioresorbable Vascular Scaffold (BVS) System made by Abbott Vascular. Unlike traditional metal stents which remain in the body permanently, the Absorb BVS dissolves into the blood vessel, leaving behind a treated vessel that is free of a permanent metallic implant.

Study subjects will be randomized to receive either the Absorb BVS or a commercially approved stent, and will be followed up for 5 years.

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This clinical trial is for men and women who are diagnosed with mitral regurgitation (MR), mitral insufficiency or mitral incompetence and are at extremely high risk for open mitral valve surgery.

The purpose of the study is to assess the safety and effectiveness of the MitraClip device, the first device for repair of the mitral valve that is delivered by a catheter, avoiding the need for heart surgery.  Half of the eligible study subjects will be randomized to undergo the MitraClip procedure, and the other half will continue to be treated according to standard medical care without the MitraClip procedure.

Study subjects will be followed up for 5 years after placement of the stent.

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Enrollment in this trial is temporarily on hold.

This clinical trial is for men and women who are diagnosed with ischemic or congestive heart failure (CHF) after a myocardial infarction (MI or “heart attack”).  

The purpose of the study is to assess the efficacy and long-term safety of the CardioKinetix Parachute device, an umbrella-shaped membrane that is is implanted inside the left ventricle of the heart. This creates a partition in the ventricle, reducing the effective size of the chamber and restoring its natural shape somewhat, which has been shown to be important for the treatment of heart failure. It is implanted with a catheter procedure, avoiding the risks of surgery.

Study subjects will be followed up for 5 years after placement of the stent.

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This clinical trial is for men and women who are diagnosed with severe aortic stenosis and are at intermediate-risk for traditional open-heart surgery for aortic valve replacement.

The purpose of the study is to assess the safety and effectiveness of the SAPIEN XT and SAPIEN 3 transcatheter heart valves. Unlike traditional replacement aortic valves, they are implanted with a catheter procedure to eliminate the need for surgery.  These devices are approved by FDA for patients who are at high-risk for traditional open-heart surgery.

Study subjects will be followed up for 5 years after placement of the stent.

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This clinical trial is for men and women diagnosed with an atrial septal defect, which is an opening between the right and left upper chambers of the heart. As part of this study, the doctor will attempt to implant the AMPLATZER™ Septal Occluder (ASO) to close this hole. The ASO is approved by the FDA to close atrial septal defects. The device, procedures and tests used in this study are not considered experimental.

The purpose of the study is to gather more information about the possible risk factors associated with the occurrence of a rare type of negative effect, called erosion, and the presence of the implanted ASO device.

Study subjects will be followed up for 12 months after the placement of the ASO.

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This clinical trial is for men and women diagnosed with coronary artery disease who qualify for stenting of coronary artery lesions.  

The purpose of the study is to evaluate the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System made by Biotronik. This is a thin, flexible stent that is coated with a material that inhibits inflammation and cell proliferation, which may reduce adverse reactions compared to other metal stents.

Study subjects will be followed up for up to 5 years after placement of the stent.

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This clinical trial is for men and women diagnosed with clinically significant functional mitral regurgitation who are determined to have an unacceptably high risk from surgery.  

The purpose of the study is to evaluate the safety and effectiveness of the MitraClip System made by Abbott Vascular, Inc. The MitraClip System is the first FDA-approved mitral valve repair therapy that is percutaneous, meaning that access to the heart is gained by means of a catheter, as with angioplasty or stenting, rather than by an open heart surgery. This provides a treatment option for select patients with mitral regurgitation.

Study subjects will be randomized in a 1:1 ratio either to receive the MitraClip device, or to be treated without the device by standard medical care. Study subjects are followed up for 5 years.

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This clinical trial is for men and women who will be treated with peripheral endovascular interventions (PEI).

The purpose of the study is to determine whether anticoagulation treatment with a drug called bivalirudin (manufactured by The Medicines Company under the trade name Angiomax®) results in fewer major bleeding complications compared with heparin in subjects undergoing PEI. Bivalrudin is an anticoagulant that may overcome many limitations seen with indirect thrombin inhibitors, such as heparin, by having a more predictable response, leaving the body more quickly, and avoiding conditions associated with the use of heparin such as thrombocytopenia.

Study subjects will be followed up for 12 months after the peripheral endovascular interventions .

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This clinical trial is for men and women who will undergo coronary angiography,  a minimally invasive catheter-based procedure to visualize the arteries that supply blood to the heart, whose procedure is likely to include IVUS (intravascular ultrasound imaging, which employs a miniaturized ultrasound probe attached to the catheter).

The purpose of this study is to determine whether detecting cholesterol-rich plaques in the coronary arteries using near-infrared light can predict future coronary problems for persons who have already experienced such problems. Study subjects will be followed up for 2 years after the coronary angiography procedure.

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This clinical trial is for men and women age 18 and older who have severe aortic valve stenosis and are scheduled to undergo a Transcatheter Aortic Valve Replacement procedure ("TAVR," also known as Transcatheter Aortic Valve Implantation or "TAVI").

The purpose of the study is to evaluate the safety and efficacy of the Sentinel™ Cerebral Protection System made by Claret Medical, Inc. The Sentinel system is intended to capture and remove blood clots that may form during a TAVR procedure so as to protect the brain from possible damage due to blockage of the arteries that supply blood to the brain.

Study subjects will be followed up for 90 days after the TAVR procedure.

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Clinical Cardiology and Heart Failure

Enrollment in this trial is temporarily on hold.

This clinical trial is for men and women who are diagnosed with ischemic or congestive heart failure (CHF) after a myocardial infarction (MI or “heart attack”).  

The purpose of the study is to assess the efficacy and long-term safety of the CardioKinetix Parachute device, an umbrella-shaped membrane that is is implanted inside the left ventricle of the heart. This creates a partition in the ventricle, reducing the effective size of the chamber and restoring its natural shape somewhat, which has been shown to be important for the treatment of heart failure. It is implanted with a catheter procedure, avoiding the risks of surgery.

Study subjects will be followed up for 5 years after placement of the stent.

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Enrollment in this study is temporarily on hold.

This clinical trial is for men and women moderate to severe heart failure (HF). The purpose of the study is to assess the safety and efficacy of the C-Pulse System, a device that is intended to relieve heart failure symptoms, improve quality of life and cardiac function, and reduce the need for heart failure hospitalization.

Unlike traditional heart assist devices, the C-Pulse system includes a small cuff around the aorta that inflates and deflates as the heart beats, increasing the heart’s oxygen supply and reducing the stress on the pumping chamber.  It is implanted outside the bloodstream, and maybe disconnected for personal hygiene.

Study subjects are follow up for five years after the device is implanted.

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This clinical trial is for men and women who are being treated for with Pulmonary Hypertension (PH) or pulmonary arterial hypertension (PAH) but continue to experience symptoms such as  shortness of breath during exertion, dizziness, or fainting spells.

The purpose of this study is to evaluate the use of inhaled nitric oxide (iNO) with a pulsed delivery device (INOpulse DS). Similar treatments are approved only for conditions found in newborn babies.

There are two parts to this study. For the first 16 weeks, subjects are randomized to receive either one of  two doses of iNO delivered by a pulsed delivery device, or a placebo. All subjects who complete this part of the study are eligible to enter an extended study in which all subjects receive iNO. This part of the study continues until the entire study is closed.

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Noninvasive Cardiac Imaging

This rearch study is for men and women who are admitted to the hospital for ST-elevated myocardial infarction (STEMI, or “heart attack”). The purpose of the study is to compare two forms of cardiac imaging—echocardiography or “echo,” and MRI—for the detection of blood clots (“thrombi”), which can cause stroke, and damage to heart’s papillary muscle, which can cause problems with the heart’s mitral valve and lead to the condition known as heart failure.

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This rearch study is for men and women who are admitted to the hospital for ST-elevated myocardial infarction (STEMI, or “heart attack”). The purpose of the study is to test whether cardiac echocardiography (“echo”) can detect blood clots, or “thrombi,” more effectively in these patients if it is performed with the addition of perflutren lipid microspheres, a contrast agent that is approved by the Food and Drug Administration (FDA) to improve detection of thrombi with echo in selected populations.

Improving detection of thrombi may help physicians to predict the risk of STEMI patients for stroke.

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Interventional Cardiology Research:
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Heart Failure Research:
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