Clinical trial NCT00187213: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Dysfunction
Heart Diseases
Keywords: Ventricular Dyssynchrony
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2005-09-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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:
measure: 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.
Other outcomes:
Locations:
city: Rennes
country: France
facility: Department of Cardiology - CHU Pontchaillou
Study officials:
affiliation: CHU Pontchaillou Rennes France
name: Christophe Leclercq, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.