NCT00187252CompletedNot Applicable
Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
Abbott Medical Devices1 site in 1 country380 target enrollmentStarted: September 1, 2003Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Abbott Medical Devices
- Enrollment
- 380
- Locations
- 1
- Primary Endpoint
- Prevalence of permanent atrial fibrillation
Study Overview
Brief Summary
The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •HF patients
- •New York Heart Association (NYHA) III - IV
- •Spontaneous QRS ≥130 ms and/or mechanical interventricular delay > 50 ms
- •Left ventricular ejection fraction (LVEF) ≤ 35%
- •Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm
- •Optimized medical regimen
- •Age > 18 years
Exclusion Criteria
- •Unstable angina or acute myocardial infarction (MI) (< 3 months)
- •Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) < 3 months
- •Life expectancy < 6 months
- •Permanent AF
- •Pregnancy
Arms & Interventions
1
Experimental
CRT + AF Suppression turned ON
Intervention: Atrial Overdrive Pacing (Device)
2
Active Comparator
CRT + AF Suppression turned OFF
Intervention: Atrial Overdrive Pacing (Device)
Outcomes
Primary Outcomes
Prevalence of permanent atrial fibrillation
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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