TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Phase 4
Completed
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00345592
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
Demonstrate the efficacy of the device-based managed therapy to treat atrial tachycardia and fibrillation (AT/AF) in patients with CHF indication for implant of a CRT defibrillator and to demonstrate the advantage of automatic electrical therapy of atrial arrhythmias compared to an in-hospital approach for treatment of symptomatic AT/AF.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
Inclusion Criteria
- chronic symptomatic HF despite stable, optimal drug therapy
- indication for a cardiac resynchronisation device with defibrillator backup according to current guidelines
- patients implanted with cardiac resynchronization device with dual (atrial and ventricular) defibrillation capabilities
Exclusion Criteria
- Chronic atrial fibrillation
- Valvular disease
- patients who underwent or are planned for ablation of atrial fibrillation
- cerebral vascular accident/transient ischemic attack within 12 months from implant which lead to relevant impairment
- preexisting unipolar pacemaker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation 3 years from randomization (39 months total)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Istituto di Clinica Medica I° e Cardiologia A.O.C.
🇮🇹Careggi, Italy
Azienda Ospedale S. Anna
🇮🇹San Fermo della Battaglia (CO), Italy
Istituto di Clinica Medica I° e Cardiologia A.O.C.🇮🇹Careggi, Italy