New Research Option Available to Heart Failure Patients
Name of Research Trial: C-Pulse™ Implantable Counterpulsation Pump (ICP)
Principal Investigator: Edwin C. McGee, Jr., MD
IRB Project Number: STU00001522
Description of Research Trial:
This research study is looking for patients who have heart failure who have become resistant to medications.
Currently, heart transplantation is the only widely accepted treatment option for patients with heart failure resistant to standard medications. Mechanical heart assist devices, pumps that do all the work of the heart to pump blood around the body, are used in some patients as a bridge-to-transplant, and in other patients who are not suitable for heart transplant, as a long-term implant (otherwise known as "destination therapy"). Such blood-contacting heart pumps require extensive surgery to implant, and cannot be turned off without the risk of permanent injury to the patient or death.
Patrick M. McCarthy, MD discusses C-Pulse™
The purpose of this research study is to evaluate a new heart assistance device, known as C- Pulse™. The C-Pulse™ device works to assist the heart to pump blood, rather than "replacing" the heart function; it does NOT contact the blood, and can be safely turned on or off as required. The C- Pulse™ is an experimental device, which means is not yet approved by the Federal and Drug Administration (FDA) in the United States.
Patients who are eligible to participate will have the study device surgically implanted. The C-Pulse™ Cuff is positioned around the aorta (the main artery coming out of the heart that delivers blood to the body). The Cuff deflates just before the heart pumps blood, reducing the workload of the heart, and the Cuff is timed to re-inflate in between heart beats, to help assist the heart in pumping blood. Reducing the load on the heart and increasing the blood flow to the heart muscle are very important in assisting the heart's ability to pump blood around the body.
There will be up to 20 patients enrolled in this study in the United States and up to 6 centers. Participation in the study and follow-up visits are expected to last up to 5 years.
Research Trial Contact Information:
For more information, interested participants and clinicians may contact, Karissa Fortney, RN, clinical research nurse at 312-926-4801 or e-mail at email@example.com