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

NCT00187213 | Completed DMC

• 1 other identifier: CR03019HF
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Ventricular Dysfunction; Heart Diseases

Keywords

Ventricular Dyssynchrony

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Cardiac Resynchronization Therapy DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Department of Cardiology - CHU Pontchaillou

Rennes, 35011, France

Location

Related Publications (1)

• Boriani G, Kranig W, Donal E, Calo L, Casella M, Delarche N, Lozano IF, Ansalone G, Biffi M, Boulogne E, Leclercq C; B-LEFT HF study group. A randomized double-blind comparison of biventricular versus left ventricular stimulation for cardiac resynchronization therapy: the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial. Am Heart J. 2010 Jun;159(6):1052-1058.e1. doi: 10.1016/j.ahj.2010.03.008.

  PMID: 20569719 DERIVED

MeSH Terms

Conditions

Heart Failure; Ventricular Dysfunction; Heart Diseases

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Officials

• Christophe Leclercq, MD, PhD

  CHU Pontchaillou Rennes France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: January 1, 2008
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)