Status:
COMPLETED
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Heart Failure
Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00187213
Start Date
December 1 2004
End Date
January 1 2008
Last Update
February 4 2019
Active Locations (1)
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1
Department of Cardiology - CHU Pontchaillou
Rennes, France, 35011