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

Withdrawn before enrolling · Not applicable

Conditions studied: Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease, Myocardial Diseases

In brief

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.

Key facts

Study ID

NCT00326690

Run by

BioVentrix

People needed

0

Starts

2005-11-01

Expected to finish

2008-12-01

Last updated by the study team

2023-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cedar Sinai Department of Cardiothoracic Surgery — Los Angeles, California, United States
• St. Joseph's Hospital — St. Petersburg, Florida, United States
• University of Maryland College of Medicine — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• NYU College of Medicine — New York, New York, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
• University of Virginia College of Medicine — Charlottesville, Virginia, United States
• St. Joseph's Hospital — Tacoma, Washington, United States
• Heart Center Leipzig — Leipzig, Germany

Full record on ClinicalTrials.gov

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