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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00345592
First received: June 27, 2006
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  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:

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):

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00345592     History of Changes
Other Study ID Numbers: 2005_TH
Study First Received: June 27, 2006
Last Updated: August 31, 2012
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 19, 2013