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

June 27, 2006
May 13, 2014
October 2006
November 2012   (final data collection date for primary outcome measure)
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 ]
  • Unplanned hospital admissions for cardiac reasons
  • Death of cardiovascular causes
  • Progression to chronic AF
Complete list of historical versions of study NCT00345592 on ClinicalTrials.gov Archive Site
Not Provided
  • Sensitivity and Specificity of automatic AT/AF detection
  • In hospital costs
  • Quality of Life
  • Total number of hospitalizations after 2 years
Not Provided
Not Provided
 
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure, Congestive
  • 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
  • Experimental: Device managed arm
    Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
    Intervention: Device: Dual (atrial and ventricular) implantable defibrillator
  • 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.
    Interventions:
    • Device: Dual (atrial and ventricular) implantable defibrillator
    • Device: Dual (atrial and ventricular) implantable defibrillator
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
420
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00345592
2005_TH
Yes
Guidant Corporation
Guidant Corporation
Not Provided
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
Guidant Corporation
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP