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

Study Overview
=================
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.

Official Title
-----------------
Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients

Conditions
-----------------
Heart Failure, Ventricular Dysfunction, Heart Diseases

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ventricular Dyssynchrony