Status:
COMPLETED
Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
Lead Sponsor:
Abbott Medical Devices
Conditions:
Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to determine efficacy of a dedicated programming concept for avoidance of inappropriate implantable cardioverter defibrillator (ICD) therapies in patient with primary prev...
Detailed Description
Inappropriate ICD therapies still remains a major issue with respect to patient's quality of life and proarrhythmic risk. It's the aim of this study to determine efficacy of a dedicated programming c...
Eligibility Criteria
Inclusion
- Approved indication for new ICD implantation for primary prevention of sudden cardiac death
- Age \>=18 Years
- Written informed consent
Exclusion
- ICD indication for secondary prevention reasons
- ICD indication for "electrical" disorders (i.e. long/short QT syndrome, Brugada syndrome etc...)
- ICD change or upgrade
- Pregnancy
- Nonage
- Patient is already participating to another study with active therapy arm
- Patient will most likely not be able to participate to the routine follow ups in the study center.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
543 Patients enrolled
Trial Details
Trial ID
NCT01217528
Start Date
August 1 2009
End Date
January 1 2013
Last Update
February 4 2019
Active Locations (34)
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1
Medizinische Einrichtungen der RWTH Aachen
Aachen, Germany, 52074
2
Klinikum Altenburger Land GmbH
Altenburg, Germany, 04600
3
Städtisches Krankenhaus St. Barbara Attendorn GmbH
Attendorn, Germany, 57439
4
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
Bonn, Germany, 53127