C-Pulse IDE Feasibility Study- A Heart Assist System
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): C-Pulse™ (Implantable Counterpulsation Therapy)
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): C-Pulse Implantable Counterpulsation System; Heart Assist System
Intervention model: Single Group Assignment
Intervention model description: The C-Pulse System is indicated for use in subjects with moderate to severe heart failure who are refractory to optimal medical therapy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Device; Implantable; Active; Class III and Class IV; Counterpulsation