The Purpose of the Study is to Evaluate Whether the Use of C-Pulse™ as Treatment for Patients in Moderate to Severe Heart Failure (HF) is Associated With Reasonable Assurance of Safety and Performance
The C-Pulse 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:||A Prospective Study to Assess the Safety and Indications of Performance of the C-Pulse™ System in Relieving Heart Failure Symptoms in Patients With ACC/AHA Stage C, NYHA Class III-ambulatory Class IV Heart Failure.|
- 1. Assess the risks with regard to the performance of the device as defined by the serious adverse event rates, under normal conditions of use. [ Time Frame: Through 6 months ] [ Designated as safety issue: Yes ]
- Assess the potential risks with regard to the performance of the device as defined by the device failure rate, adverse event rates, re-hospitalization rates, duration of support, and length of time to hospital discharge. [ Time Frame: Through 6 months ] [ Designated as safety issue: Yes ]
- Assess the potential benefits of C-Pulse as defined by improvements in quality of life, fatigue impact scales, hemodynamics, 6 minute hall walk test, myocardial perfusion. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||October 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Implantable Counterpulsation Therapy
The study is a single arm study with up to 20 patients enrolled and implanted with implantable counterpulsation. Patients that meet eligibility will be enrolled and implanted into the treatment arm of the study. There is not a control arm in this feasibility study.
Device: C-Pulse™ (Implantable Counterpulsation Therapy)
Implantation of a heart assist device that provide counterpulsation without blood contact for an extended period.
Other Names: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 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: NCT01176370
|McGill University Health Centre - Royal Victoria Hospital|
|Montreal, Quebec, Canada, QcH3A 1A1|
|Principal Investigator:||Renzo Cecere, MD||McGill University Health Centre, Royal Victoria Hospital|