38
Participants
Start Date
September 12, 2012
Primary Completion Date
September 19, 2018
Study Completion Date
October 26, 2018
C-Pulse® System Counterpulsation
The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
Cornell University, New York - Presbyterian Hospital, New York
Westchester Medical Center, Valhalla
Allegheny-Singer Research Institute - Allegheny General Hospital, Pittsburgh
Hershey Medical Center, Hershey
Hospital of the University of Pennsylvania, Philadelphia
Temple University, Philadelphia
VCU Medical Center, Richmond
Charlotte-Mecklenburg Hospital - Carolinas Health Care System, Charlotte
Medical Center of Central Georgia, Macon
Memorial Healthcare System, Hollywood
University of Miami Medical Center, Miami
Morton Plant Hospital, Clearwater
The University of Alabama at Birmingham Hospital, Birmingham
Vanderbilt University Medical Center, Nashville
University of Mississippi Medical Center, Jackson
University of Louisville - Jewish Hospital, Louisville
The Ohio State University Medical Center, Columbus
St. Louis Heart and Vascular, St Louis
Mid America Heart Institute-Saint Luke's Hospital, Kansas City
Nebraska Heart Institute, Lincoln
Ochsner Medical Center, New Orleans
Cardiovascular Institute of the South, Houma
Dallas VA Medical Center, Dallas
Texas Heart Institute - St Luke's Hospital, Houston
University of Southern California Keck School of Medicine, Los Angeles
University of California San Francisco, San Francisco
Providence Sacred Heart Medical Center, Spokane
Newark Beth Israel Medical Center, Newark
Lead Sponsor
Nuwellis, Inc.
INDUSTRY