Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity

Sponsor

BioVentrix (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT00326690

Collaborator

(none)

Enrollment

Locations

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure Ischemic Cardiomyopathy Coronary Artery Disease Myocardial Diseases	Device: Blue Egg Device	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

A 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. []

Secondary Outcome Measures

Secondary objectives will examine the difference in heart failure symptoms between the two groups. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Be 18 years of age or older
Have symptomatic heart failure consistent with NYHA Class III or IV
Have been treated, in the opinion of the Principal Investigator, for at least 12 weeks with an optimized pharmacological regimen, including no substantial dosage titration for the last 4 weeks. This will typically mean that the subject has had (unless intolerant) appropriate doses of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers (β-blockers) and/or aldosterone inhibitors and diuretics.
Have a dilated left ventricular (LV) with an LV end-systolic volume index (LVESVI) of 60 ml/m² and an akinetic or dyskinetic anterior wall
Have an LV ejection fraction less than or equal to 35%
Have an MVO2 of equal to or greater than 10, but equal to or less than 16 ml O2/min/kg
Have demonstrated myocardial infarction without viability on a dobutamine stress echocardiogram in a region considered for surgery. Alternatively, have demonstrated the same physiological feature with gadolinium/magnetic resonance imaging (MRI) procedures or other sophisticated methodology for viability assessment.
Agree to be compliant with the study protocol and willing and able to return for follow-up

Exclusion Criteria:

Have had a myocardial infarction within 90 days of consent
Be inotrope or intra-aortic balloon pump (IABP) dependent
Require, in the judgment of the Principal Investigator, cardiac surgery that cannot be deferred for 6 months, such as subjects with:
left main coronary artery disease
intractable ventricular arrhythmias
Canadian Cardiovascular Society Angina Class III or IV symptoms
aortic stenosis or insufficiency requiring replacement
3+ or 4+ mitral regurgitation
Have any comorbid medical condition that is a contraindication to cardiac surgery (e.g., renal failure, coagulopathy, severe chronic obstructive pulmonary disease [COPD], cerebrovascular accident [CVA], prior stroke, known malignancy etc.)
Have congestive heart failure (CHF) due to a cause other than ischemic cardiomyopathy
Have a history of radiation therapy to the chest or mediastinum
Have exercise tolerance limited by a condition other than heart failure
Be unable to perform cardiopulmonary stress test
Have a history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation or realization of benefit from the trial in the opinion of the Principal Investigator.
Be a female of child-bearing age who is pregnant or does not agree to use standard methods of birth control.
Carry a diagnosis of an illness other than CHF with life expectancy less than 12 months.
Participating in another trial (other than non-therapeutic or interventional observation) within the last 30 days or less than 60 days after completion of a heart failure drug trial.
Biventricular pacemaker implantation and/or activation within the past 60 days
Percutaneous coronary intervention (PCI) with coronary revascularization within the last 60 days.
More than one prior sternotomy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedar Sinai Department of Cardiothoracic Surgery	Los Angeles	California	United States	90048
2	St. Joseph's Hospital	Saint Petersburg	Florida	United States	33709
3	University of Maryland College of Medicine	Baltimore	Maryland	United States	21201
4	University of Michigan	Ann Arbor	Michigan	United States	48109
5	NYU College of Medicine	New York	New York	United States	10016
6	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
7	University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania	United States	19104
8	University of Virginia College of Medicine	Charlottesville	Virginia	United States	22908
9	St. Joseph's Hospital	Tacoma	Washington	United States	98405
10	Heart Center Leipzig	Leipzig		Germany	39 04289

Sponsors and Collaborators

BioVentrix

Investigators

Principal Investigator: Robert R. Lazzara, MD, St. Joseph's Hospital
Principal Investigator: Ulrich Jorde, MD, New York College of Medicine
Principal Investigator: Francis Pagani, MD, University of Michigan
Principal Investigator: James D. Bergin, MD, University of Virginia College of Medicine
Principal Investigator: Howard J Eisen, MD, Drexel University College of Medicine
Principal Investigator: Ernst Schwarz, MD, Cedar Sinai Department of Cardiothoracic Surgery
Principal Investigator: Volkmar Falk, MD, Heart Center Leipzig
Principal Investigator: Mariell Jessup, MD, University of Pennsylvania
Principal Investigator: Erika Feller, MD, University of Maryland College of Medicine
Principal Investigator: Rosemary Peterson, MD, St. Joseph's Hospital - Tacoma, WA