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

NCT00326690 | Withdrawn

• 1 other identifier: BioVentrix - Blue Egg Trial™
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 10

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.

Conditions

Congestive Heart Failure; Ischemic Cardiomyopathy; Coronary Artery Disease; Myocardial Diseases

Keywords

Congestive Heart Failure; Coronary Artery Disease; Ischemic Cardiomyopathy; Idiopathic Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

treatment

EXPERIMENTAL

Device: Blue Egg Device

Control

NO INTERVENTION

Interventions

Blue Egg Device DEVICE

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• + 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.

Sponsors & Collaborators

• BioVentrix: lead

Study Sites (10)

Cedar Sinai Department of Cardiothoracic Surgery

Los Angeles, California, 90048, United States

Location

St. Joseph's Hospital

St. Petersburg, Florida, 33709, United States

Location

University of Maryland College of Medicine

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

NYU College of Medicine

New York, New York, 10016, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia College of Medicine

Charlottesville, Virginia, 22908, United States

Location

St. Joseph's Hospital

Tacoma, Washington, 98405, United States

Location

Heart Center Leipzig

Leipzig, 39 04289, Germany

Location

Related Publications (13)

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MeSH Terms

Conditions

Heart Failure; Coronary Artery Disease; Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2006
• First Posted: May 17, 2006
• Study Start: November 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

DE (1); US (9)