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TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

NCT00345592 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2017-03-28

Study results available
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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

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Gianluca Botto, MD · Azienda Ospedale S. Anna

  • Luigi Padeletti, MD · Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00345592 on ClinicalTrials.gov