NCT00345592

TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 420 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	Dual (atrial and ventricular) implantable defibrillator	The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
DEVICE	Dual (atrial and ventricular) implantable defibrillator	In hospital application of anti arrhythmic therapies via the device
DEVICE	Dual (atrial and ventricular) implantable defibrillator	Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment

Timeline

• Start date: 2006-10-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2006-06-28
• Last updated: 2017-03-28
• Results posted: 2014-06-11

Locations

2 sites across 1 country: Italy