Status:
COMPLETED
TReatment of Atrial Fibrillation With Dual dEfibrillator in Heart Failure Patients
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00345592
Start Date
October 1 2006
End Date
November 1 2012
Last Update
March 28 2017
Active Locations (2)
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1
Istituto di Clinica Medica I° e Cardiologia A.O.C.
Careggi, Italy
2
Azienda Ospedale S. Anna
San Fermo Della Battaglia (CO), Italy