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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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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)

Study Contacts: PI: Parag Goyal, MD (646) 962 5555

                           RC:  Astrid Carmona   (212) 746 2623

 

 

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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

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

                           RC:  Katelyn Bastert,  (212) 746 2698

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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

Study Contacts: PI: Evelyn Horn, MD

                           RC: Astrid Carmona, 212 746 2623

 

 

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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.

Study Contacts: PI: Evelyn Horn, MD

                           RC: Astrid Carmona, 212 746 2623

 

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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.

Study Contacts: PI: Evelyn Horn, MD

                           RC: Astrid Carmona, 212 746 2623

 

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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.

Read More

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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Cardiology Services
for Researchers

Grants and Clinical Trials Central Administration:
(212) 746 4617

Electrophysiology Research:
(212) 746 4857

Interventional Cardiology Research:
(212) 746 4617

Heart Failure Research:
(212) 746 2698

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