TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients (TRADE HF)

Boston Scientific

Status and phase: Completed; Phase 4

Conditions: Heart Failure, Congestive

Treatments: Device: Dual (atrial and ventricular) implantable defibrillator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345592

2005_TH

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Device managed arm

Experimental group

Description:

Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.

Treatment:

Device: Dual (atrial and ventricular) implantable defibrillator

Device: Dual (atrial and ventricular) implantable defibrillator

Device: Dual (atrial and ventricular) implantable defibrillator

Traditional arm

Active Comparator group

Description:

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.

Treatment:

Device: Dual (atrial and ventricular) implantable defibrillator

Device: Dual (atrial and ventricular) implantable defibrillator

Device: Dual (atrial and ventricular) implantable defibrillator