TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients (TRADE HF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00345592
First received: June 27, 2006
Last updated: May 13, 2014
Last verified: May 2014
  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:


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 ]

Enrollment: 420
Study Start Date: October 2006
Study Completion Date: November 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00345592     History of Changes
Other Study ID Numbers: 2005_TH
Study First Received: June 27, 2006
Results First Received: April 4, 2014
Last Updated: May 13, 2014
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 July 22, 2014