C-Pulse IDE Feasibility Study- A Heart Assist System
The C-Pulse Feasibility Study is evaluating the safety and performance of a new product for the treatment of heart failure. The product is designed to help reduce the symptoms of heart failure and help patients function better with daily activities. The study evaluates multiple measures of heart function and whether the patient's quality of life has been improved since the device implant. The patient will have several visits after the device implant to assess how well they are doing and to monitor any safety concerns.
Device: C-Pulse™ (Implantable Counterpulsation Therapy)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||C-Pulse Implantable Counterpulsation Pump (ICP) Feasibility Study - A Heart Assist System|
- The safety will be evaluated by reviewing a composite of the device-related adverse events through six months, as classified by the CEC. [ Time Frame: Through 6 months ] [ Designated as safety issue: Yes ]
- The efficacy will be evaluated by assessing: Peak VO2, MLWHF, NYHA, 6MHW [ Time Frame: Through 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Implantable Counterpulsation Therapy
The study is a single arm study with 20 patients being treated with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. These patients will receive the C-Pulse System Implant as intervention therapy. There is not a control arm in this feasibility study.
Device: C-Pulse™ (Implantable Counterpulsation Therapy)
Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
Sunshine Heart Inc. is sponsoring a prospective, multi-center trial to assess the safety and provide indications for performance of the Sunshine Heart C-PulseTM System ("C-Pulse™").
The current need is for a counterpulsation device or method that is effective enough to make its application appealing as a long-term implant to a large number of patients and physicians. It must be simple and safe, with a straight-forward implant procedure, and with long-term measurable patient benefits. Further, it would be advantageous for the counterpulsation device to be smaller, easier to insert, ambulatory, disconnectable, and not in the bloodstream. Such a device may be more readily adopted by a wider group of cardiologists and surgeons, and be suitable for a wider group of people in NYHA Class III or IV heart failure. It is important to point out that a counterpulsation device is aimed to augment native heart function and is fundamentally different from total artificial hearts, left ventricular assist devices and heart transplants which are meant to be a total replacement or an alternative to the native heart. Thus, the counterpulsation device is considered non-obligatory and not life-supporting.
Sunshine Heart, Inc has proposed C-Pulse™, a novel ambulatory, non-obligatory, non-blood contacting extra-ascending aortic counterpulsation system. The C-Pulse™ System is designed to be implanted without the need for cardiopulmonary bypass or extensive dissection, to be able to be activated immediately, to augment heart function in a safe manner and to provide sustained relief from heart failure symptoms. It can be turned off safely, and similarly, in failure modes, is considered to have an associated low risk of death or disability, other than the recurrence of heart failure symptoms. C-Pulse™ is not an alternative to the heart, it is an augmentation device, and it does not preclude the use of therapies that provide full circulatory support such as heart transplantation or LVADs.
The C-Pulse™ System consists of a counterpulsation Cuff secured around the outside of the ascending aorta, the main blood vessel out of the heart. The Cuff and a heart signal sensing wire are attached to an external driver. The external Driver inflates and deflates the Cuff in sequence with the ECG signal to assist heart function and improve the pumping capacity of the heart. The Cuff deflects the aorta in a "thumb-printing" manner which has been optimized to minimize aortic wall strain and maximize blood volume displacement per beat. The C-Pulse™ System is non-blood contacting, simple to insert, and can be turned on and off as required; all natural blood pathways are maintained - there is no exposure of foreign material to the bloodstream.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00815880
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Minnesota|
|St. Paul Heart Clinic|
|St. Paul, Minnesota, United States, 55102|
|United States, Missouri|
|Mid America Heart Institute-Saint Luke's Hospital|
|Kansas City, Missouri, United States, 64111|
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|United States, Pennsylvania|
|Penn State Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||William T Abraham, MD||Ohio State University|
|Principal Investigator:||Pat McCarthy, MD||Northwestern University|