A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 18
- Primary Endpoint
- 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.
Study Overview
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 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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Time Frame: 6 months
Secondary Outcomes
- Secondary objectives will examine the difference in heart failure symptoms between the two groups.(6 months)