TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Boston Scientific Corporation420 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Heart Failure, Congestive

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Istituto di Clinica Medica I° e Cardiologia A.O.C.

Careggi, Italy

Azienda Ospedale S. Anna

San Fermo Della Battaglia (CO), Italy

Outcomes

Primary Outcomes

Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation

Time frame: 3 years from randomization (39 months total)

Data from ClinicalTrials.gov

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