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Study overviews


Study Title: LONG-TERM FOLLOW-UP FOR PARTICIPANTS OF: EVALUATION OF OUTCOMES FOLLOWING MITRAL VALVE REPAIR/REPLACEMENT IN SEVERE CHRONIC ISCHEMIC MITRAL REGURGITATION (SMR) AND SURGICAL INTERVENTIONS FOR MODERATE ISCHEMIC MITRAL REGURGITATION (MMR) TRIALS

Current Status: Enrolling

Study Overview

This study is a continuation of two previous studies --- the Severe Ischemic Mitral Regurgitation (SMR) Trial and the Moderate Ischemic Mitral regurgitation (MMR) Trial--- to learn more about patients' health 5-10 years after their mitral valve surgeries. The investigators will collect long-term health information on SMR and MMR trial participants using electronic medical records, patient and/or family input, public records, and healthcare- and vital status-related databases.

For more information on this study, please click here

GCO # 08-1078(12); Current IRB approval period 12/22/2016-12/21/2017


Study Title: Rate Control Versus Rhythm Control for Postoperative Atrial Fibrillation

Current Status: Enrollment Complete
Total Enrolled: 523

Study Overview

The purpose of the research is to compare two strategies for treating atrial fibrillation or atrial flutter, both of which are referred to as AF, after cardiac surgery. AF is when the upper chambers of your heart (atria) experiences disorganized electrical activity which causes your heart beat to be irregular. AF is the most common complication after cardiac surgery. The two treatment strategies to be used in this study are called rhythm control and rate control. The rhythm control strategy will attempt to bring your heart beat back to a regular rhythm using treatments known and approved to control heart rhythm. The rate control strategy will attempt to bring your heart rate to less than 100 beats per minute at rest using medications known and approved to control heart rate. Both strategies are commonly used to treat AF. This research seeks to determine whether rhythm control is better than rate control in patients with AF after cardiac surgery. People who are undergoing cardiac surgery to treat coronary artery disease (a narrowing of the small blood vessels that supply blood and oxygen to the heart), and possibly a disease of one or more of your heart valves may take part in this research study.

For more information on this study, please click here.
This trial will randomize a total of 520 patients at 25 sites. To view enrolling sites click here

GCO# 08-1078(7); Current annual IRB approval period: 4/22/17 - 4/21/18


Study Title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

Current Status: Enrolling

Currently Enrolled: 158/159 Patients
Top Enrolling Sites
Duke University28
University of Michigan24
Stanford University17
Toronto General Hospital13
University of Pennsylvania12

Study Overview

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. This study will test to see if these effects are enough to improve overall heart function. People who are scheduled for surgery to implant an LVAD as either bridge-to-transplant (BTT) or as destination therapy (DT) may take part in this research study. MPCs are an investigational product, meaning that they have not been approved by the FDA.

For more information on this study, please click here.
(https://www.clinicaltrials.gov/ct2/show/NCT02362646?term=NCT02362646&rank=1)

GCO # 08-1078(8); Current IRB approval period 12/13/16-12/8/17


Study Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement

Current Status: Enrollment Complete
Total Enrolled: 383

Study Overview

All patients undergoing cardiac surgery, including AVR, face a risk for injury to the brain including stroke. 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) during the surgery. It can travel to the brain or other organs (such as the kidneys) and cause injury. The Food and Drug Administration (FDA) has cleared two devices for use during cardiac surgery to capture this debris. These devices include the CardioGard Cannula and the Edwards Embol-X. The researchers in this study are seeking to learn how well these devices reduce the risk of stroke or other injury to the brain. Patients aged 65 years or older scheduled for surgery for an aortic valve replacement (AVR) may participate in this study. There will be a total of 495 to 535 participants enrolled in this study in a number of medical centers (up to 25) across the United States and Canada.

For more information on this study, please click here.
(https://clinicaltrials.gov/ct2/show/NCT02389894)

GCO # 08-1078(9); Current IRB approval period 1/20/17-1/19/18


Study Title: EVALUATING THE BENEFIT OF CONCURRENT TRICUSPID VALVE REPAIR DURING MITRAL SURGERY

Current Status: Enrolling

Currently Enrolled: 123/400 Patients
Top Enrolling Sites
University of Maryland20
Duke University19
Cleveland Clinic Foundation14
University of Virginia Health System12
Baylor Institute, Hôpital Laval, London Health Sciences Centre10

Study Overview

The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. What is not known with certainty, but what will be tested in this study, is whether patients with a smaller amount of leakage of the tricuspid valve (mild or moderate TR) would benefit from the repair in addition to the mitral valve surgery. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

For more information on this study, please click here.
(https://www.clinicaltrials.gov/ct2/show/NCT02675244)
This trial will randomize a total of 400 patients at up to 40 sites.

GCO # 08-1078(10); Current annual IRB approval period: 4/11/17-2/15/18