NCT00187213
Completed
N/A
Biventricular Versus Left Univentricular Pacing With ICD Back-up in Heart Failure Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Abbott Medical Devices
- Locations
- 1
- Primary Endpoint
- The primary objective is to demonstrate that left univentricular pacing is equivalent to biventricular pacing in improving the functional capacity and inducing reverse remodeling.
- Status
- Completed
- Last Updated
- 7 years ago
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.
Investigators
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)
Outcomes
Primary Outcomes
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
- 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.
Study Sites (1)
Loading locations...
Similar Trials
Withdrawn
Phase 4
Biventricular Alternative PacingAtrioventricular BlockNCT00559143Medtronic Hellas Medical Devices ΑEE38
Completed
Phase 1
A Study to Determine the Effect of Bi-Ventricular Pacing on Cardiac Hemodynamics After Coronary Artery Bypass GraftCoronary DiseaseNCT00316368Unity Health Toronto60
Withdrawn
N/A
Left Ventricular Pacing to Avoid Cardiac Enlargement StudyComplete AV BlockSick Sinus SyndromeNCT01302717Seoul National University Hospital
Unknown
N/A
BiventRicular Pacing in prolongEd Atrio-Ventricular intervaL: the REAL-CRT StudyFirst Degree Atrioventricular BlockNCT02150538Gianluca Botto164
Completed
N/A
Biventricular Pacing and Cardiac PhysiologyISRCTN75745362Record Provided by the NHSTCT Register - 2006 Update - Department of Health