Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00382863
Status:
TERMINATED
Last Update Posted:
2012-07-13
First Post:
2006-09-28
Brief Title:
Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure PEERLESS-HF Trial
Sponsor:
Paracor Medical Inc
Organization:
Paracor Medical Inc
Study Overview
Official Title:
Prospective Evaluation of Elastic Restraint to LESSen the Effects of Heart Failure PEERLESS-HF Trial
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Resources unavailable to continue study follow-up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEERLESS-HF
Brief Summary:
The purpose of this study is to determine if patients in the HeartNet Ventricular Support System with optimal medical and device therapy arm Treatment group show statistically significant improvement compared to patients in the optimal medical and device therapy alone arm Control group after 6 months of follow-up
Detailed Description:
In the United States alone more than five million people suffer from heart failure CHF and an estimated 400000 to 700000 new cases are diagnosed each year Caused by a variety of cardiac conditions systolic heart failire HF is the end-stage of heart disease where the heart is failing as a pump Once diagnosed with the disease less than 50 of the patients live for five years and less than 25 survive for more than ten years The number of deaths in the United States from this condition has more than doubled since 1979 averaging more than 250000 annually
Paracor Medical Inc has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress
The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy Treatment group when compared to optimal medical and device therapy ie medications cardiac resynchronisation therapy pacemaker alone Control group as treatments for patients with heart failure
Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests Peak VO2 six 6 minute walk distance and quality of life assessment as measured by the Minnesota Living with Heart Failure MLWHF questionnaire
Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate
Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration
Paracor Medical Inc has developed an elastic prosthetic wrap that is designed to apply a gentle mechanical support to the failing heart The Implant is a compliant elastic structure that is designed to conform to the epicardial surface of the right and left ventricles It supports the heart throughout the cardiac cycle and was designed to offload the ventricles and reduce wall stress
The objective of this clinical trial is to evaluate the safety and efficacy of the HeartNet Ventricular Support System with optimal medical and device therapy Treatment group when compared to optimal medical and device therapy ie medications cardiac resynchronisation therapy pacemaker alone Control group as treatments for patients with heart failure
Efficacy of the HeartNet Ventricular Support System in the Treatment group compared to the optimal medical and device therapy Control group will be evaluated based upon cardiopulmonary tests Peak VO2 six 6 minute walk distance and quality of life assessment as measured by the Minnesota Living with Heart Failure MLWHF questionnaire
Safety of the HeartNet Ventricular Support System in the Treatment group compared to the Control group will be evaluated based on the all-cause mortality rate
Paracor Medical intends to submit data obtained in this clinical trial to support a Pre-Market Approval Application to the United States Food and Drug Administration
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