TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
NCT ID: NCT00345592
Last Updated: 2017-03-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
420 participants
INTERVENTIONAL
2006-10-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Interventions
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Dual (atrial and ventricular) implantable defibrillator
The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Gianluca Botto, MD
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedale S. Anna
Luigi Padeletti, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto di Clinica Medica I° e Cardiologia A.O.C. Careggi
Locations
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Istituto di Clinica Medica I° e Cardiologia A.O.C.
Careggi, , Italy
Azienda Ospedale S. Anna
San Fermo Della Battaglia (CO), , Italy
Countries
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References
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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.
Other Identifiers
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2005_TH
Identifier Type: -
Identifier Source: org_study_id
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