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

Primary Purpose

Heart Failure, Ventricular Dysfunction, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac Resynchronization Therapy
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Ventricular Dyssynchrony

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiology - CHU Pontchaillou

Outcomes

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.

Full Information

First Posted
September 13, 2005
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00187213
Brief Title
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
Official Title
Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Dysfunction, Heart Diseases
Keywords
Ventricular Dyssynchrony

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Cardiac Resynchronization Therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Leclercq, MD, PhD
Organizational Affiliation
CHU Pontchaillou Rennes France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology - CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35011
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20569719
Citation
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.
Results Reference
derived

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

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