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

Primary Purpose

Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blue Egg Device
Sponsored by
BioVentrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive Heart Failure, Coronary Artery Disease, Ischemic Cardiomyopathy, Idiopathic Cardiomyopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cedar Sinai Department of Cardiothoracic Surgery
  • St. Joseph's Hospital
  • University of Maryland College of Medicine
  • University of Michigan
  • NYU College of Medicine
  • Drexel University College of Medicine
  • University of Pennsylvania School of Medicine
  • University of Virginia College of Medicine
  • St. Joseph's Hospital
  • Heart Center Leipzig

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

treatment

Control

Arm Description

Outcomes

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.

Full Information

First Posted
May 15, 2006
Last Updated
January 24, 2023
Sponsor
BioVentrix
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1. Study Identification

Unique Protocol Identification Number
NCT00326690
Brief Title
Study Tests Whether a Standardized LVR Performed With the Blue Egg Device Improves Cardiopulmonary Exercise Capacity
Official Title
A Prospective, Randomized Trial Using a reproduciBLe volUmE-Measurement stratEGy in the surGical Reconstruction of the Ischemic Cardiomyopathic Heart
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit and enroll patients
Study Start Date
November 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioVentrix

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Ischemic Cardiomyopathy, Coronary Artery Disease, Myocardial Diseases
Keywords
Congestive Heart Failure, Coronary Artery Disease, Ischemic Cardiomyopathy, Idiopathic Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
treatment
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Blue Egg Device
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Secondary objectives will examine the difference in heart failure symptoms between the two groups.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert R. Lazzara, MD
Organizational Affiliation
St. Joseph's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ulrich Jorde, MD
Organizational Affiliation
New York College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis Pagani, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James D. Bergin, MD
Organizational Affiliation
University of Virginia College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Howard J Eisen, MD
Organizational Affiliation
Drexel University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ernst Schwarz, MD
Organizational Affiliation
Cedar Sinai Department of Cardiothoracic Surgery
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Volkmar Falk, MD
Organizational Affiliation
Heart Center Leipzig
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariell Jessup, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erika Feller, MD
Organizational Affiliation
University of Maryland College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosemary Peterson, MD
Organizational Affiliation
St. Joseph's Hospital - Tacoma, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedar Sinai Department of Cardiothoracic Surgery
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
St. Joseph's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
University of Maryland College of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
NYU College of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Virginia College of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
St. Joseph's Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
39 04289
Country
Germany

12. IPD Sharing Statement

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

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