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

Abbott

Status

Completed

Conditions

Ventricular Dysfunction

Heart Failure

Heart Diseases

Treatments

Device: Cardiac Resynchronization Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00187213

CR03019HF

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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