Phase 4
Completed N=396
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Heart Failure, Congestive
Source: ClinicalTrials.gov NCT00345592 ↗
Enrolled (actual)
396
Serious AEs
49.5%
Results posted
Jun 2014
Primary outcomePrimary: Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation — 43; 44 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation |
43; 44 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00345592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.