CTSN

What is a clinical trial?

Clinical trials are studies conducted on people to determine whether a drug, therapy, surgical or behavioral intervention, or a medical device is safe and effective in treating specific medical conditions.

Clinical trials are a crucial step in the clinical research path toward providing better treatments for people burdened by a disease or medical condition.

Clinical trials typically require cooperation and coordination among physicians and other health care providers, patients, government agencies, and industry.

The objective of the Cardiothoracic Surgical Trials Network (CTSN) is to conduct clinical trials that advance therapy for patients suffering from cardiac disease.

CTSN is committed to enrolling diverse populations of patients. All patients who meet eligibility criteria will be included in the study regardless of gender, race or ethnicity.

Why should you join a trial?

There are many potential benefits from participating in a clinical trial. Patients in clinical trials receive additional attention from health care providers as the study schedule may require more visits for clinical follow-up than otherwise offered by standard care.

In addition, clinical trial participants have the opportunity to receive novel interventions that are not yet available to all patients.

Although patients may not directly benefit from participating in a trial, the information gained from the trial may improve survival, quality of life or other relevant clinical outcomes for future patients with the same condition.

Which trial will be best for your condition?

Cardiovascular diseases affect primarily older adults with two-third of cardiovascular deaths occurring in individuals older than 75 years of age. CTSN trials focus on adult patients across the spectrum of cardiovascular disorders and do not include children (individuals less than 18 years of age).

The following CTSN trials are currently enrolling study participants.

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

The purpose of this trial is to compare the risks and benefits of two different procedures used to help patients with mitral valve regurgitation. Mitral valve regurgitation is a condition where the valve does not close fully when it is supposed to, and some blood can then leak back into the left atrium instead of circulating to the rest of the body.

The PRIMARY trial will compare two treatment options for mitral valve regurgitation:
(1) transcatheter edge-to-edge repair, which is a catheter procedure for repairing the mitral valve that doesn’t require surgery to open up the heart, and
(2) mitral valve repair surgery, which is an open-heart surgical procedure.

There are no new or experimental procedures being tested in this trial: both treatment options are well-established treatments and are regularly performed in patients who have mitral valve regurgitation. However, the Food and Drug Administration (FDA) has not approved the investigational catheter device used in the TEER repair procedure for all types of patients with MR. Similarly, in Canada, Germany and the United Kingdom these devices are considered investigational for certain types of patients.

If you are eligible to participate in this trial, this means that both procedures are safe for you. However, if you participate you will not be able to choose which procedure you will receive.

This study will enroll 450 patients with mitral valve regurgitation in up to 100 clinical centers in the United States, Canada, Europe, and the United Kingdom.

The duration of the study is 10 years.

To learn more about this clinical trial, please email: Chari Ponder (Chari.Ponder@mountsinai.org)

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG (PACeS)

The purpose of this trial is to compare two commonly used treatment strategies for managing atrial fibrillation after cardiac surgery.

Atrial fibrillation is the most common irregular heartbeat that occurs in some patients after they undergo coronary artery bypass surgery. It can develop when the upper chambers of the heart (atria) produces a disorganized electrical activity, which then causes the heart to beat irregularly. Patients who have this heart beat irregularity are at a higher risk of developing blood clots in the heart, which can cause a stroke, and result in death.

There are two classes of drugs for preventing blood clots: antiplatelet drugs and anticoagulants. Antiplatelet drugs prevent clots from forming and growing by stopping blood cell fragments, called platelets, from clumping together.

Anticoagulants work differently. They affect the reaction of the clotting proteins in the blood, so that the blood is “thinner” and less likely to form a clot. These drugs can also cause bleeding more easily.

This trial aims to determine which treatment works best in patients who develop atrial fibrillation after coronary artery bypass surgery.

This study will enroll 3,200 patients who develop AF after coronary artery bypass surgery in up to 100 clinical centers in the United States, Canada, Europe, the United Kingdom and Brazil.

The duration of the study is 6 months.

To learn more about this clinical trial, please email: Jonathan Hupf (Jonathan.Hupf@mountsinai.org)

Embolic Protection in Patients Undergoing High-Risk Valve Surgery (EMPRO)

Patients WHO undergo heart surgery face a risk for injury to the brain including stroke. During the surgery, debris such as plaque, may be dislodged from the wall of the aorta (the large blood vessel leading from the heart to the brain and the rest of the body). Debris can travel to the brain or other organs (such as the kidneys) and cause injury.

The Food and Drug Administration (FDA) has cleared a device, the CardioGard Cannula, for use during cardiac surgery to capture such debris, when it occurs. The researchers in this study are seeking to learn how well this device reduces the risk of stroke or other injury to the brain or injury to the kidneys from such debris after heart surgery.

This trial will examine how well patients do after surgery when the CardioGard cannula is used compared to how well patients do who receive surgery with the standard of care cannula.

This study will enroll 842 patients undergoing heart surgery in clinical centers in the United States and Canada.

The duration of the study is 1 year.

To learn more about this clinical trial, please email: Claudia Merlin (Claudia.Merlin@mountsinai.org)