CardioFit™ for the Treatment of Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Congestive Heart Failure is the result of a number of diseases affecting the heart, causing
      the heart's failure to properly meet the body demands for blood circulation. In spite of
      advances in drug therapy, it remains a significant public health problem.

      Pharmacologic antagonism of the beta-adrenergic receptors shifting the autonomic balance in
      the direction of greater vagal influence is a well-proven treatment for heart failure
      patients, although there are patients who cannot tolerate, or only partially benefit from
      such a treatment.

      It has been proven in the past and well established that parasympathetic nerve stimulation
      can slow the rate of the heart and reduce the workload of the heart. Therefore, the potential
      benefit of vagus nerve stimulation, hence parasympathetic activation, for treatment of heart
      failure is substantial.

      In this study, the safety and efficacy of a new vagus nerve stimulating system will be
      evaluated. This study will compare whether the new device improves Heart Failure parameters
      in Class II - III Heart Failure patients.
    

Detailed description: 
      -  Purpose of the study: To determine the safety and efficacy of the CardioFit™ system for
           treatment of Class II-III Heart Failure patients.

        -  Study hypothesis: CardioFit system treatment will improve patients Heart Failure
           parameters.

        -  Tested hypothesis: Thirty patients are required to provide 80% power at 95% confidence
           level in order to detect 12 points difference on a quality of life questionnaire between
           pre- and post activation.

        -  Design: Prospective, self-controlled interventional study composed of 5 periods:
           Pre-implantation, Implantation, Device activation, Follow-up (with active device) and
           post-study extension period.

        -  Study duration is 7.5-months per patient. At the end of the study, patients enter an
           extension period (with active devices) during which they will be monitored for quality
           of life and survival, for up to 3 years post-implantation in 6-months intervals.

        -  Study Endpoints:

             -  Primary endpoints: The occurrence of all system and/or procedure related adverse
                events.

             -  Secondary endpoints: changes in the following individual variables as well as in a
                composite score of individual variables change: NYHA class; Quality of Life;
                Exercise capacity (by 6-min walk); LV Ejection fraction; LV end-systolic and
                end-diastolic volumes; blood tests.

        -  Up to 10 participating centers in Europe, Israel and Australia
    

Intervention name(s): Implantation and activation of the vagus nerve stimulator
Intervention type(s): Procedure
Intervention description(s): Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment