Trials / Withdrawn
WithdrawnNCT00326690
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- BioVentrix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 1.2 ml O2/min/kg greater than the average change observed in the control group in the same time frame.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Blue Egg Device |
Timeline
- Start date
- 2005-11-01
- Primary completion
- 2008-12-01
- Completion
- 2008-12-01
- First posted
- 2006-05-17
- Last updated
- 2023-01-26
Locations
10 sites across 2 countries: United States, Germany
Source: ClinicalTrials.gov record NCT00326690. Inclusion in this directory is not an endorsement.