B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients

This study has been completed.
Sponsor:
Information provided by:
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187213
First received: September 13, 2005
Last updated: February 21, 2008
Last verified: February 2008
  Purpose

The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients implanted with a cardiac resynchronization therapy defibrillator (CRT-D) device.

The hypothesis to be tested by this clinical investigation is that patients indicated for an ICD with cardiac resynchronization therapy respond as well to LV only pacing as to BiV pacing.


Condition Intervention
Heart Failure
Ventricular Dysfunction
Heart Diseases
Device: Cardiac Resynchronization Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.

Secondary Outcome Measures:
  • The secondary objective of this clinical investigation is to evaluate the proportion of improved patients in each group, using the Heart Failure Clinical Composite Response.

Study Start Date: December 2004
Study Completion Date: January 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have an approved indication for implantation of an ICD for treatment of a life-threatening ventricular tachyarrhythmia(s)
  • Have advanced heart failure with a New York Heart Association (NYHA) classification of III or IV, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
  • Have a ventricular conduction delay manifested as a QRS width >= 130 ms
  • Have a left ventricular end diastolic diameter (LVEDD) >= 55 mm
  • Have a left ventricular ejection fraction (LVEF) <= 35%

Exclusion Criteria:

  • Have a CRT device already implanted
  • Have a standard indication for bradycardia pacing
  • Have a history of chronic atrial fibrillation [AF] (continuous AF lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for AF in the past month)
  • Have the ability to walk > 450 meters during the 6-minute walk test
  • Have uncorrected primary valvular disease
  • Have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [PTCA] or coronary artery bypass graft [CABG]) within 1 month of enrollment
  • Have had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months of enrollment
  • Have a life expectancy of less than one year
  • Are unable to comply with the follow-up schedule and tests
  • Are minors (age below 18 years)
  • Are pregnant or are planning for pregnancy in the next 6 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187213

Locations
France
Department of Cardiology - CHU Pontchaillou
Rennes, France, 35011
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Christophe Leclercq, MD, PhD CHU Pontchaillou Rennes France
  More Information

No publications provided by St. Jude Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christophe Bailleul, St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187213     History of Changes
Other Study ID Numbers: CR03019HF
Study First Received: September 13, 2005
Last Updated: February 21, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by St. Jude Medical:
Ventricular Dyssynchrony

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Ventricular Dysfunction
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014