Skip to main content
OpenTrials
Completed

NCT Number: NCT00187213

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Ventricular Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Cardiology - CHU Pontchaillou

Rennes, 35011, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cardiac resynchronization therapy

Device

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.

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2007
Study completion
2008
First posted
Sep 16, 2005
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.