Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy

Abbott Medical Devices1 site in 1 country380 target enrollmentSeptember 2003

ConditionsHeart Failure Atrial Fibrillation Ventricular Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Abbott Medical Devices
Enrollment: 380
Locations: 1
Primary Endpoint: Prevalence of permanent atrial fibrillation
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 2003

End Date

June 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Eligibility Criteria

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