Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461019
Status:
COMPLETED
Last Update Posted:
2011-03-07
First Post:
2007-04-16
Brief Title:
CardioFit for the Treatment of Heart Failure
Sponsor:
BioControl Medical
Organization:
BioControl Medical
Study Overview
Official Title:
CardioFiT for Heart Failure - Safety and Efficacy Study Protocol
Status:
COMPLETED
Status Verified Date:
2011-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Congestive Heart Failure is the result of a number of diseases affecting the heart causing the hearts 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
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 75-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 andor 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
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 75-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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None