TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients - Full Text View

Sponsor:	Guidant Corporation
Information provided by:	Guidant Corporation
ClinicalTrials.gov Identifier:	NCT00345592

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Device: Dual (atrial and ventricular) implantable defibrillator	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation Heart Failure Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Further study details as provided by Guidant Corporation:

Primary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity and Specificity of automatic AT/AF detection [ Time Frame: 3 years from randomization (39 months total) ] [ Designated as safety issue: No ]
In hospital costs [ Time Frame: All in hospital costs 3 years from randomization (39 months total) ] [ Designated as safety issue: No ]
Total number of hospitalizations after 3 years [ Time Frame: 3 years from randomization (39 months total) ] [ Designated as safety issue: No ]

Estimated Enrollment:	414
Study Start Date:	October 2006
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Device managed arm Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.	Device: Dual (atrial and ventricular) implantable defibrillator The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
Active Comparator: Traditional arm 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: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345592

Locations

Italy
Istituto di Clinica Medica I° e Cardiologia A.O.C.
Careggi, Italy
Azienda Ospedale S. Anna
San Fermo della Battaglia (CO), Italy

Sponsors and Collaborators

Guidant Corporation

Investigators

Principal Investigator:	Gianluca Botto, MD	Azienda Ospedale S. Anna
Principal Investigator:	Luigi Padeletti, MD	Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi

More Information

No publications provided by Guidant Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Botto GL, Boriani G, Favale S, Landolina M, Molon G, Tondo C, Biffi M, Grandinetti G, De Filippo P, Raciti G, Padeletti L. Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial. Trials. 2011 Feb 15;12:44.

Responsible Party:	Giovanni Raciti, Guidant Ialia
ClinicalTrials.gov Identifier:	NCT00345592 History of Changes
Other Study ID Numbers:	2005_TH
Study First Received:	June 27, 2006
Last Updated:	May 9, 2011
Health Authority:	Italy: Ministry of Health

Additional relevant MeSH terms:

Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac

Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2012