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
Results First Received: April 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Heart Failure, Congestive
Intervention: Device: Dual (atrial and ventricular) implantable defibrillator

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient was enrolled on the 3rd of October, 2006. Last patient was enrolled on the 29th of July 2009, for a total of 420 patients.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

24 subjects were not randomized:

  • 7 died before randomization (causes: 3 cardiac, 2 non-cardiac, 2 unknown);
  • 7 voluntarily withdrew;
  • 5 withdrawn due to AF.
  • 2 had device explanted before randomization;
  • 1 had biventricular pacing turned OFF
  • 1 was withdrawn from the study for inclusion criteria violation;
  • 1 lost to follow up.

Reporting Groups
  Description
Device Managed Arm

Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.

Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.

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.

Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the 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


Participant Flow:   Overall Study
    Device Managed Arm     Traditional Arm  
STARTED     199     197  
COMPLETED     174     173  
NOT COMPLETED     25     24  
Death                 14                 16  
Withdrawal by Subject                 11                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Device Managed Arm

Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.

Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.

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.

Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the 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

Total Total of all reporting groups

Baseline Measures
    Device Managed Arm     Traditional Arm     Total  
Number of Participants  
[units: participants]
  199     197     396  
Age  
[units: years]
Mean ± Standard Deviation
  67  ± 10     68  ± 10     67  ± 10  
Gender  
[units: participants]
     
Female     47     38     85  
Male     152     159     311  
Region of Enrollment  
[units: participants]
     
Italy     199     197     396  



  Outcome Measures

1.  Primary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Giovanni Luca Botto
Organization: S. Anna Hospital
phone: 0315851 ext +39
e-mail: gluca.botto@gmail.com


No publications provided by Guidant Corporation

Publications automatically indexed to this study:

Responsible Party: Guidant Corporation
ClinicalTrials.gov Identifier: NCT00345592     History of Changes
Other Study ID Numbers: 2005_TH
Study First Received: June 27, 2006
Results First Received: April 4, 2014
Last Updated: May 13, 2014
Health Authority: Italy: Ministry of Health