CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 420 enrolled
Drug / intervention
Dual (atrial and ventricular) implantable defibrillator +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00345592
NCT00345592Phase 4Completed
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TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Boston Scientific Corporation·interventional·Posted Jun 28, 2006·Updated Mar 28, 2017

In Brief

A Phase 4 clinical trial evaluating Dual (atrial and ventricular) implantable defibrillator for Heart Failure, Congestive. Completed, enrolled 420 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Congestive
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 28, 2006
Enrollment StartOct 1, 2006
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.0 years ago

Interventions

Dual (atrial and ventricular) implantable defibrillatordevice

The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.

Dual (atrial and ventricular) implantable defibrillatordevice

In hospital application of anti arrhythmic therapies via the device

Dual (atrial and ventricular) implantable defibrillatordevice

Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment