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
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)|
|Intervention Model:||Parallel Assignment|
|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|
- The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
- 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.
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|
|Principal Investigator:||Christophe Leclercq, MD, PhD||CHU Pontchaillou Rennes France|