TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Phase 4

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Device: Dual (atrial and ventricular) implantable defibrillator

• 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

Study Timeline

• Study First Submitted: 2006-06-27
• Study First Submitted QC: 2006-06-27
• Study First Posted: 2006-06-28
• Study Start: 2006-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Results First Submitted: 2014-04-04
• Results First Submitted QC: 2014-05-13
• Results First Posted: 2014-06-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-27
• Last Update Posted: 2017-03-28

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

Arm && Interventions

Group	Intervention	Description
Traditional arm	Dual (atrial and ventricular) implantable defibrillator	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 managed arm	Dual (atrial and ventricular) implantable defibrillator	Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.

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)

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