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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345592
First Posted: June 28, 2006
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Scientific Corporation
  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: None (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 Boston Scientific 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Boston Scientific 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT00345592     History of Changes
Other Study ID Numbers: 2005_TH
First Submitted: June 27, 2006
First Posted: June 28, 2006
Results First Submitted: April 4, 2014
Results First Posted: June 11, 2014
Last Update Posted: March 28, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes