Heart Failure Clinical Trial
Official title:
CardioFiT™ for Heart Failure - Safety and Efficacy Study Protocol
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.
- 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
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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