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

January 24, 2023 updated by: BioVentrix

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 39 04289
        • Heart Center Leipzig
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedar Sinai Department of Cardiothoracic Surgery
    • Florida
      • Saint Petersburg, Florida, United States, 33709
        • St. Joseph's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland College of Medicine
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • New York
      • New York, New York, United States, 10016
        • NYU College of Medicine
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania School of Medicine
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia College of Medicine
    • Washington
      • Tacoma, Washington, United States, 98405
        • St. Joseph's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: treatment
Device: Blue Egg Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary objectives will examine the difference in heart failure symptoms between the two groups.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 15, 2006

First Submitted That Met QC Criteria

May 15, 2006

First Posted (Estimate)

May 17, 2006

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BioVentrix - Blue Egg Trial™

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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