Clinical trial NCT00326690: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Congestive Heart Failure
Ischemic Cardiomyopathy
Coronary Artery Disease
Myocardial Diseases
Keywords: Congestive Heart Failure
Coronary Artery Disease
Ischemic Cardiomyopathy
Idiopathic Cardiomyopathy
Lead sponsor: BioVentrix
Sponsor class: INDUSTRY
First posted: 2006-05-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary objectives will examine the difference in heart failure symptoms between the two groups.
timeFrame: 6 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar Sinai Department of Cardiothoracic Surgery
state: California
city: Saint Petersburg
country: United States
facility: St. Joseph's Hospital
state: Florida
city: Baltimore
country: United States
facility: University of Maryland College of Medicine
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: NYU College of Medicine
state: New York
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania School of Medicine
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia College of Medicine
state: Virginia
city: Tacoma
country: United States
facility: St. Joseph's Hospital
state: Washington
city: Leipzig
country: Germany
facility: Heart Center Leipzig
Study officials:
affiliation: St. Joseph's Hospital
name: Robert R. Lazzara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York College of Medicine
name: Ulrich Jorde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Francis Pagani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia College of Medicine
name: James D. Bergin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel University College of Medicine
name: Howard J Eisen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedar Sinai Department of Cardiothoracic Surgery
name: Ernst Schwarz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Leipzig
name: Volkmar Falk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Mariell Jessup, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland College of Medicine
name: Erika Feller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Hospital - Tacoma, WA
name: Rosemary Peterson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abraham WT, Fisher WG, Smith AL, Delurgio DB, Leon AR, Loh E, Kocovic DZ, Packer M, Clavell AL, Hayes DL, Ellestad M, Trupp RJ, Underwood J, Pickering F, Truex C, McAtee P, Messenger J; MIRACLE Study Group. Multicenter InSync Randomized Clinical Evaluation. Cardiac resynchronization in chronic heart failure. N Engl J Med. 2002 Jun 13;346(24):1845-53. doi: 10.1056/NEJMoa013168.
citation: Athanasuleas CL, Stanley AW Jr, Buckberg GD, Dor V, DiDonato M, Blackstone EH. Surgical anterior ventricular endocardial restoration (SAVER) in the dilated remodeled ventricle after anterior myocardial infarction. RESTORE group. Reconstructive Endoventricular Surgery, returning Torsion Original Radius Elliptical Shape to the LV. J Am Coll Cardiol. 2001 Apr;37(5):1199-209. doi: 10.1016/s0735-1097(01)01119-6.
citation: Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM; Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) Investigators. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med. 2004 May 20;350(21):2140-50. doi: 10.1056/NEJMoa032423.
citation: Cohn JN. The Vasodilator-Heart Failure Trials (V-HeFT). Mechanistic data from the VA Cooperative Studies. Introduction. Circulation. 1993 Jun;87(6 Suppl):VI1-4. No abstract available.
citation: Hjalmarson A, Goldstein S, Fagerberg B, Wedel H, Waagstein F, Kjekshus J, Wikstrand J, El Allaf D, Vitovec J, Aldershvile J, Halinen M, Dietz R, Neuhaus KL, Janosi A, Thorgeirsson G, Dunselman PH, Gullestad L, Kuch J, Herlitz J, Rickenbacher P, Ball S, Gottlieb S, Deedwania P. Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group. JAMA. 2000 Mar 8;283(10):1295-302. doi: 10.1001/jama.283.10.1295.
citation: Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML; Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002 Mar 21;346(12):877-83. doi: 10.1056/NEJMoa013474. Epub 2002 Mar 19.
citation: Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group. N Engl J Med. 1996 May 23;334(21):1349-55. doi: 10.1056/NEJM199605233342101.
citation: Packer M, Coats AJ, Fowler MB, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Castaigne A, Roecker EB, Schultz MK, DeMets DL; Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med. 2001 May 31;344(22):1651-8. doi: 10.1056/NEJM200105313442201.
citation: Pitt B, Remme W, Zannad F, Neaton J, Martinez F, Roniker B, Bittman R, Hurley S, Kleiman J, Gatlin M; Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med. 2003 Apr 3;348(14):1309-21. doi: 10.1056/NEJMoa030207. Epub 2003 Mar 31.
citation: Pitt B, Zannad F, Remme WJ, Cody R, Castaigne A, Perez A, Palensky J, Wittes J. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med. 1999 Sep 2;341(10):709-17. doi: 10.1056/NEJM199909023411001.
citation: Rose EA, Gelijns AC, Moskowitz AJ, Heitjan DF, Stevenson LW, Dembitsky W, Long JW, Ascheim DD, Tierney AR, Levitan RG, Watson JT, Meier P, Ronan NS, Shapiro PA, Lazar RM, Miller LW, Gupta L, Frazier OH, Desvigne-Nickens P, Oz MC, Poirier VL; Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Study Group. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med. 2001 Nov 15;345(20):1435-43. doi: 10.1056/NEJMoa012175.
citation: Starling RC, McCarthy PM, Buda T, Wong J, Goormastic M, Smedira NG, Thomas JD, Blackstone EH, Young JB. Results of partial left ventriculectomy for dilated cardiomyopathy: hemodynamic, clinical and echocardiographic observations. J Am Coll Cardiol. 2000 Dec;36(7):2098-103. doi: 10.1016/s0735-1097(00)01034-2.
citation: Young JB, Abraham WT, Smith AL, Leon AR, Lieberman R, Wilkoff B, Canby RC, Schroeder JS, Liem LB, Hall S, Wheelan K; Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE ICD) Trial Investigators. Combined cardiac resynchronization and implantable cardioversion defibrillation in advanced chronic heart failure: the MIRACLE ICD Trial. JAMA. 2003 May 28;289(20):2685-94. doi: 10.1001/jama.289.20.2685.