Study Title: Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients
Current Status: Enrollment Complete
| Top Enrolling Sites | |
|---|---|
| Duke University | 28 |
| University of Michigan | 25 |
| Stanford University | 17 |
| Toronto General Hospital | 13 |
| University of Pennsylvania | 12 |
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 12/2/19-12/1/20
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(3); Current annual IRB approval period: 10/16/18 - 10/9/19
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(4); Current annual IRB approval period: 3/26/18 - 3/25/19
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(2); Current annual IRB approval period: 10/16/18 - 10/9/19
Study Title: LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function
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
GCO# 08-1078(6); Current annual IRB approval period: 10/11/18 - 10/10/19
Study Title: Management Practices and the Risk of Infections Following Cardiac Surgery
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(5); Current annual IRB approval period: 11/20/18-11/19/19
Study Title: Hybrid Revascularization Observational Study
Study Overview
The purpose of this observational study, funded by an external ARRA Grant and conducted by CTSN and non-CTSN participating sites, was to gain 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] (a 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 collected information about the medical care received during the planned procedure(s) and how well patients did following the procedure(s). The information collected informed the design of a randomized trial of Hybrid coronary revas-cularization that is currently being considered for funding by NHLBI.
For more information on this study, please click here.
This study enrolled 6881 patients at CTSN network sites. To view enrolling sites click
here
Current annual IRB approval period: 3/19/18-3/18/19.
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: 4/22/18 - 4/21/19
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 1/20/19-1/19/20
