Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
NCT ID: NCT01217528
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
543 participants
INTERVENTIONAL
2009-08-31
2013-01-31
Brief Summary
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Detailed Description
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It's the aim of this study to determine efficacy of a dedicated programming concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A
Group A:
* VT zone: 350ms
* VF zone: 280ms
device settings for group A
VT zone: 350ms VF zone: 280ms
Group B
Group B:
* VT zone: 320ms
* VF zone: 250ms
Device settings for group B
VT zone: 320ms VF zone: 250ms
Interventions
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device settings for group A
VT zone: 350ms VF zone: 280ms
Device settings for group B
VT zone: 320ms VF zone: 250ms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \>=18 Years
* Written informed consent
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg O Schwab, Prof. Dr. med.
Role: PRINCIPAL_INVESTIGATOR
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn
Locations
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Medizinische Einrichtungen der RWTH Aachen
Aachen, , Germany
Klinikum Altenburger Land GmbH
Altenburg, , Germany
Städtisches Krankenhaus St. Barbara Attendorn GmbH
Attendorn, , Germany
Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
Bonn, , Germany
Klinikum Coburg
Coburg, , Germany
Evangelisches Krankenhaus Kalk
Cologne, , Germany
Klinik Fränkische Schweiz
Ebermannstadt, , Germany
Kreiskrankenhaus Ebersberg
Ebersberg, , Germany
Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
Erfurt, , Germany
Klinikum Esslingen
Esslingen am Neckar, , Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, , Germany
Krankenhaus Waltershausen-Friedrichroda
Friedrichroda, , Germany
Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
Giessen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitäres Herzzentrum Hamburg
Hamburg, , Germany
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Henningsdorf, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel
Kiel, , Germany
Frankenwaldklinik Kronach GmbH
Kronach, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
St.-Marien-Hospital GmbH
Lünen, , Germany
Klinikum Memmingen
Memmingen, , Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, , Germany
Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Praxis Dres. med. Haggenmiller / Jeserich
Nuremberg, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Kreiskrankenhaus des Bördekreises Krankenhaus 4
Oschersleben, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, , Germany
Klinikum Pirna GmbH Klinik für Innere Medizin II
Pirna, , Germany
Klinikum Dorothea Christiane Erxleben GmbH
Quedlinburg, , Germany
Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes
Ratzeburg, , Germany
Universität Rostock
Rostock, , Germany
Katharinen-Hospital gGmbH
Unna, , Germany
Helios Klinikum Wuppertal
Wuppertal, , Germany
Countries
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References
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Schwab JO, Bonnemeier H, Kleemann T, Brachmann J, Fischer S, Birkenhauer F, Eberhardt F. Reduction of inappropriate ICD therapies in patients with primary prevention of sudden cardiac death: DECREASE study. Clin Res Cardiol. 2015 Dec;104(12):1021-32. doi: 10.1007/s00392-015-0870-z. Epub 2015 May 23.
Other Identifiers
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T76
Identifier Type: -
Identifier Source: org_study_id
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