TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Study Overview
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Brief Summary
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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.

Official Title
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TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Dual (atrial and ventricular) implantable defibrillator
* Device: Dual (atrial and ventricular) implantable defibrillator
* Device: Dual (atrial and ventricular) implantable defibrillator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device managed arm<br>Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device. | Device: Dual (atrial and ventricular) implantable defibrillator<br>* The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.<br>|
| Active Comparator: Traditional arm<br>Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias. | Device: Dual (atrial and ventricular) implantable defibrillator<br>* In hospital application of anti arrhythmic therapies via the device<br>Device: Dual (atrial and ventricular) implantable defibrillator<br>* Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation |  | 3 years from randomization (39 months total) |