Back to resultsTReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients (TRADE HF)
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Dual (atrial and ventricular) implantable defibrillator
Dual (atrial and ventricular) implantable defibrillator
Dual (atrial and ventricular) implantable defibrillator
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive
Eligibility 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
Sites / Locations
- Istituto di Clinica Medica I° e Cardiologia A.O.C.
- Azienda Ospedale S. Anna
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Device managed arm
Traditional arm
Arm Description
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
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.
Outcomes
Primary Outcome Measures
Unplanned Hospital Admissions for Cardiac Reasons OR Death of Cardiovascular Causes OR Progression to Chronic Atrial Fibrillation
Secondary Outcome Measures
Full Information
NCT ID
NCT00345592
First Posted
June 27, 2006
Last Updated
February 27, 2017
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00345592
Brief Title
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Acronym
TRADE HF
Official Title
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Device managed arm
Arm Type
Experimental
Arm Description
Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.
Arm Title
Traditional arm
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Dual (atrial and ventricular) implantable defibrillator
Intervention Description
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
Intervention Type
Device
Intervention Name(s)
Dual (atrial and ventricular) implantable defibrillator
Intervention Description
In hospital application of anti arrhythmic therapies via the device
Intervention Type
Device
Intervention Name(s)
Dual (atrial and ventricular) implantable defibrillator
Intervention Description
Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gianluca Botto, MD
Organizational Affiliation
Azienda Ospedale S. Anna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Padeletti, MD
Organizational Affiliation
Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istituto di Clinica Medica I° e Cardiologia A.O.C.
City
Careggi
Country
Italy
Facility Name
Azienda Ospedale S. Anna
City
San Fermo della Battaglia (CO)
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
21324118
Citation
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. doi: 10.1186/1745-6215-12-44.
Results Reference
derived
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TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
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