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

February 27, 2017 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
3 years from randomization (39 months total)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

June 27, 2006

First Submitted That Met QC Criteria

June 27, 2006

First Posted (Estimate)

June 28, 2006

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005_TH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure, Congestive

Clinical Trials on Dual (atrial and ventricular) implantable defibrillator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe