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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 12/22/17-12/21/18


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

Current Status: Enrollment Complete

Currently Enrolled: 159/159 Patients
Top Enrolling Sites
Duke University28
University of Michigan25
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 12/7/17-12/8/18


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

Current Status: Enrollment Complete

Currently Enrolled: 401/401 Patients
Top Enrolling Sites
London Health Sciences Center43
University of Maryland39
Duke University37
Baylor Research Institute32
University of Virginia28
Hôpital Laval27

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: 2/16/18-2/15/19