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Study overviews

Study Title: Surgical Ablation Versus No Surgical Ablation for Patients with Persistent or Longstanding Persistent Atrial Fibrillation Undergoing Mitral Valve Surgery

Current Status: Enrollment Complete.

Study overview

The purpose of the research is to determine whether surgical atrial fibrillation ablation performed during scheduled mitral valve surgery (surgery to repair a heart valve, a part of the heart which helps control the flow of blood) is better than mitral valve surgery by itself without the surgical ablation. Surgical ablation of atrial fibrillation is a technique used by surgeons to create scars in atrial heart tissue that block electrical signals that may be causing the heart to beat irregularly. People who have mitral valve disease requiring surgery and atrial fibrillation may take part in this research study.

For more information on this study, please click here.
This trial will enroll a total of 260 patients at 20 sites. To view enrolling sites click here

GCO# 08-1078 Current annual IRB approval period: 3/26/12 - 3/25/13; Rev 4.4 approved 5/29/12.


Study Title: Surgical Interventions for Moderate Ischemic Mitral Regurgitation

Current Status: Enrollment Complete.

Study Overview

The purpose of the research is to determine whether repairing a mitral valve (a heart valve which helps control the flow of blood) with moderate leakage (regurgitation), at the time of planned coronary artery bypass graft (CABG) surgery, will improve health outcomes of those who receive it compared to those who have the bypass alone. People who have coronary artery heart disease, requiring a CABG surgery, and have leakage (regurgitation) of the mitral valve may take part in this research study.

For more information on this study, please click here.
This trial will enroll a total of 300 patients at 30 sites. To view enrolling sites click here

GCO# 08-1078 Current annual IRB approval period: 10/10/12 - 10/9/13; Rev 4.4 approved 10/10/11


Study Title: LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function

Current Status: Enrollment Complete

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 and 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.

For more information on this study, please click here.
This trial enrolled a total of 30 patients at 13 sites. To view enrolling sites click here

Initial annual IRB approval period: 10/25/12 - 10/10/13


Study Title: Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation

Current Status: Enrollment Complete

Study Overview

The purpose of this research is to determine whether it is better to repair or replace the mitral valve (a heart valve which helps control the flow of blood) of patients with severe mitral valve leakage (regurgitation) from coronary artery disease. People who have mitral valve leakage (regurgitation), which may be severe, may take part in this research study.

For more information on this study, please click here.
This trial enrolled a total of 251 patients at 22 sites. To view enrolling sites click here

GCO# 08-1078 Current annual IRB approval period: 10/10/12 - 10/9/13


Study Title: Management Practices and the Risk of Infections Following Cardiac Surgery

Current Status: Enrollment Complete

Study Overview

The purpose of the study is to determine the best ways to prevent infections after heart surgery. The study will only collect information about the care people receive during planned heart surgery. We call this kind of study an "observational study," because all we plan to do is observe the care you receive and how well you do during your treatment. People who have had or are scheduled to have heart surgery may take part in this observational study.

For more information on this study, please click here.
This trial enrolled a total of 5158 patients at 10 sites.

GCO# 08-1078 Current annual IRB approval period: 11/20/12 - 11/19/13


Study Title: HYBRID REVASCULARIZATION OBSERVATIONAL STUDY
(COHORT 1 & 2)

Current Status: Enrollment Complete

Study Overview

The purpose of the study is to get a better understanding of patients who have multi-vessel coronary artery disease (blockages in more than one vessel bringing blood to the heart) and have either Hybrid Coronary Revascularization [HCR] (combination of surgery and catheter procedures to open up clogged heart arteries) or Percutaneous Coronary Intervention [PCI] (catheter procedures to open up clogged heart arteries). The study will collect information about the medical care you receive during your planned procedure(s) and how well you do following the procedure(s). We call this kind of study an “observational study” because all we plan to do is observe the care you receive and how well you do during and after your treatment. The information we collect should help us to improve the quality of heart care in the future.

For more information on this study, please click here.
This study enrolled 6881 patients at CTSN network sites. To view enrolling sites click here

IRB approved through 3/18/13.