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Study overviews

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

Current Status: Open to Enrollment

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 Current annual IRB approval period: 4/22/15 - 4/21/16


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 enrolled a total of 260 patients at 20 sites. To view enrolling sites click here

GCO# 08-1078 Current annual IRB approval period: 3/26/15 - 3/25/16


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 enrolled a total of 301 patients at 26 sites. To view enrolling sites click here

GCO# 08-1078 Current annual IRB approval period: 10/10/14 - 10/9/15


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: 10/10/14 - 10/9/15


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

Current Status: Not Yet Enrolling

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 1/21/15-12/8/15


Study Title: Neuroprotection In Patients Undergoing Aortic Valve Replacement

Current Status: Enrolling

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 2/23/15-1/19/16