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Clinical and Translational Research and Open Clinical Trials


The Weill Cornell Medicine Division of Cardiology continues its legacy of contributing to cutting-edge research that advanced understanding and treatment of cardiological conditions. With funding from the National Institute of Health and other organizations, our Cardiologists are investigating some of the most pressing health questions of our day.

Current areas of research include investigating clinical outcomes; mitral and tricuspid regurgitation; leadless pacemakers; fundamental mechanisms of arrhythmia; EBR ultrasound technology for CRT therapy; mitral, tricuspid, and pulmonary valve devices; and others.

As a world-renowned academic medical center, medical students, post-doctoral students, residents, and fellows research under the guidance of faculty mentors to enhance their training and assist in Weill Cornell Medicine’s contribution to scientific and medical advancements.

 

Information for Patients: How to Participate in a Cardiology Clinical Trial

Deciding to Volunteer

Volunteers are an integral part of the research process. People with a particular disease and healthy people can both play a role in contributing to medical advances. Without volunteers, clinical studies simply would not be possible.

People volunteer for clinical studies for many reasons:

  • A desire to improve medical care for future generations
  • A connection to a certain disease or illness, whether through personal experience or through friends or family
  • A personal interest in science

Volunteering for a clinical study is a personal choice. You have no obligation to do so, and participation is not right for everyone. After enrolling in a study you may leave at any time, for any reason.

Making an Informed Decision

Informed consent: Before deciding to participate in a study, you will be asked to review an informational document called an informed consent form. This form will provide key facts about the study so that you can decide if participating is right for you. You must sign the informed consent form in order to participate in the study, though it is not a contract, you may still choose to leave the study at any time.

Risks and benefits: All medical research involves some level of risk to participants. Risks and benefits vary depending on the particular study. To help you make an informed decision, the study team is required to tell you about all known risks, benefits and available alternative health care options.

Ask questions: If you have questions when deciding to join a research study or at any time throughout, ask a member of the study team. If your questions or concerns are not satisfactorily addressed, contact the study's principal investigator, the Weill Cornell Medicine research subject advocate or the Weill Cornell Medicine Institutional Review Board (IRB).

Protecting rights and safety: A dedicated board of Weill Cornell Medicine medical specialists carefully reviews all potential clinical trials before making them available to you. However, it is important that you understand the potential benefits and risks of participation in any research study.

 

Clinical Trials Open to Patients

Cardiology patients have the option to participate in one or more clinical trial. Open trials are listed below by condition.

Aortic Stenosis

This condition is the narrowing of the opening of the aortic valve, due to abnormalities or aging of the valve. About five percent of heart defects are due to aortic valve stenosis. However, there may be many cases that are not diagnosed. It is likely that the most common cardiac defect.

Clinical trials for aortic stenosis patients:

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

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

 

Coronary Artery Disease

Coronary artery disease can cause angina, heart attacks or sudden death. Signs include:

  • An indigestion-like sensation of heaviness, squeezing or burning in the chest or any portion of the upper left side of the body
  • Irregular or fast heartbeat
  • Difficulty breathing
  • Dizziness or nausea
Clinical trials for coronary artery disease patients:

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 

Physiologic Assessment of Coronary Stenosis Following PCI (DEFINE PCI)

Heart Failure with Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a form of congestive heart failure where the amount of blood pumped from the heart's left ventricle with each beat (ejection fraction) is greater than 50 percent. There is a query about the relationship between diastolic heart failure and HFpEF.

Clinical trials for HFpEF patients:

SERENADE/AC-055-G202 study - Macitentan in Heart Failure, A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease

Congenital Heart Disease

Pulmonary Hypertension

Pulmonary hypertension is a type of high blood pressure that affects the arteries in the lungs and the right side of the heart. In one form of pulmonary hypertension, tiny arteries in the lungs, called pulmonary arterioles, and capillaries become narrowed, blocked or destroyed. This makes it harder for blood to flow through the lungs, and raises pressure within the lungs' arteries. As the pressure builds, the heart's lower right chamber (right ventricle) must work harder to pump blood through the lungs, eventually causing the heart muscle to weaken and fail.

Some forms of pulmonary hypertension are serious conditions that become progressively worse and are sometimes fatal. Although some forms of pulmonary hypertension aren't curable, treatment can help lessen symptoms and improve your quality of life.

 

Clinical trials for pulmonary hypertension patients:

SOPRANO, #AC-055-205: A prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of macitentan in patients with pulmonary hypertension after left ventricular assist device implantation.

INCREASE 201: A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease

INCREASE 202:  An Open-label extension study of Inhaled Treprostinil in Subjects with Pulmonary Hypertension due to Parenchymal Lung Disease (INCREASE RIN-PH-202)

Mitral Valve Disease

Cardiac Imaging

Cardiac Arrhythmia

Heart Block

Heart block is an abnormal heart rhythm where the heart beats too slowly (bradycardia ). In this condition, the electrical signals that tell the heart to contract are partially or totally blocked between the upper chambers (atria) and the lower chambers (ventricles).

Clinical trials for patients with heart block:

The AdaptResponse Study

  

Ventricular Tachycardia

Ventricular tachycardia is a heart rhythm disorder (arrhythmia) caused by abnormal electrical signals in the lower chambers of the heart (ventricles).

A healthy heart normally beats about 60 to 100 times a minute when at rest and is defined by signals that originate in the upper chambers of the heart (atria).

In ventricular tachycardia (V-tach or VT), abnormal electrical signals in the ventricles cause the heart to beat faster than normal, usually 100 or more beats a minute, out of sync with the upper chambers.

When that happens, the heart may not be able to pump enough blood to the body and lungs because the chambers are beating so fast or out of sync with each other that they don't have time to fill properly.

Ventricular tachycardia may be brief, lasting for only a few seconds, and perhaps not cause any symptoms. Or it can last for much longer and cause symptoms such as dizziness, lightheadedness, palpitations or even loss of consciousness.

In some cases, ventricular tachycardia can cause the heart to stop (sudden cardiac arrest), which is a life-threatening medical emergency. This condition usually occurs in people with other heart conditions, such as those who have had a previous heart attack or other structural heart disease (cardiomyopathy).

Clinical trials for patients with ventricular tachycardia:

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

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

 

Supraventricular Tachycardia (SVT)

Supraventricular tachycardia (SVT), also called paroxysmal supraventricular tachycardia, is defined as an abnormally fast heartbeat. It's a broad term that includes many forms of heart rhythm problems (heart arrhythmias) that originate above the ventricles (supraventricular) in the atria or AV node.

A normal heart rate is 60 to 100 beats per minute. A heart rate of more than 100 beats per minute is called a tachycardia. This occurs when the electrical impulses that coordinate the heartbeats don't work properly. It may feel like a fluttering or racing heart.

Most people with rare episodes of supraventricular tachycardia live healthy lives without restrictions or interventions. For others, treatment and lifestyle changes can often control or eliminate rapid heartbeats.

Clinical trials for patients with supraventricular tachycardia:

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

Heart Block (Bradycardia)

Heart block is an abnormal heart rhythm where the heart beats too slowly (bradycardia ). In this condition, the electrical signals that tell the heart to contract are partially or totally blocked between the upper chambers (atria) and the lower chambers (ventricles).

Current clinical trials for patients with bradycardia:

The AdaptResponse Study

SJM Brady MRI Post Approval Study

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

Medtronic Product Surveillance Registry

Cardiac Resynchronization Therapy for Non-Responders

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