We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00187213
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 22, 2008
Information provided by:
St. Jude Medical

Brief Summary:

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 or disease Intervention/treatment
Heart Failure Ventricular Dysfunction Heart Diseases Device: Cardiac Resynchronization Therapy

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
Study Start Date : December 2004
Primary Completion Date : July 2007
Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187213

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

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
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: February 22, 2008
Last Verified: February 2008

Keywords provided by St. Jude Medical:
Ventricular Dyssynchrony

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