NCT00461019

CardioFit™ for the Treatment of Heart Failure

CardioFiT™ for Heart Failure - Safety and Efficacy Study Protocol

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: BioControl Medical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure

Interventions

Type	Name	Description
PROCEDURE	Implantation and activation of the vagus nerve stimulator	Implantation of the nerve stimulator, cuff nerve electrode and RV sensing lead

Timeline

• Start date: 2007-02-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2007-04-17
• Last updated: 2011-03-07

Locations

6 sites across 4 countries: Germany, Italy, Netherlands, Serbia