Ignite Creation Date:
2024-05-05 @ 4:49 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00326690
Status:
WITHDRAWN
Last Update Posted:
2023-01-26
First Post:
2006-05-15
Brief Title:
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
Sponsor:
BioVentrix
Organization:
BioVentrix
Study Overview
Official Title:
A Prospective Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart
Status:
WITHDRAWN
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to recruit and enroll patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present prospective randomized study is to investigate the clinical effectiveness of standardized left ventricular reconstruction surgery LVR In order to standardize the procedure the operation will be performed with the Blue Egg manufactured by BioVentrix a subsidiary of CHF Technologies Inc
Detailed Description:
The primary objective of this study is to test whether a standardized Left Ventricular Reconstruction LVR performed with the Blue Egg device improves cardiopulmonary exercise capacity in subjects with stable New York Heart Association NYHA Class III or IV heart failure due to ischemic cardiomyopathy with an akinetic or dyskinetic anterior wall This shall be accomplished by comparing changes in cardiopulmonary exercise between a group of subjects treated with LVR and optimal medical therapy Treatment to a group treated with optimal medical therapy alone Control
Secondary objectives will examine the difference in heart failure symptoms between the two groups
The primary hypothesis is that the average change in peak oxygen consumption MVO2 observed in the treatment group from baseline to 6 months post surgery date is at least 12 ml O2minkg greater than the average change observed in the control group in the same time frame
Secondary objectives will examine the difference in heart failure symptoms between the two groups
The primary hypothesis is that the average change in peak oxygen consumption MVO2 observed in the treatment group from baseline to 6 months post surgery date is at least 12 ml O2minkg greater than the average change observed in the control group in the same time frame
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