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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 prevention ICD indication.
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 concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A:
|
|
| Group B | Experimental | Group B:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| device settings for group A | Device | VT zone: 350ms VF zone: 280ms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Endpoint | Event free survival of:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of patients with appropriate / inappropriate ICD therapies | 12 months | |
| Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD | 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jörg O Schwab, Prof. Dr. med. | Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Einrichtungen der RWTH Aachen | Aachen | 52074 | Germany | |||
| Klinikum Altenburger Land GmbH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26002818 | Derived | 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. |
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| Device settings for group B | Device | VT zone: 320ms VF zone: 250ms |
|
|
| Number and cycle lengths of supraventricular / ventricular tachys |
| 12 months |
| Time to first appropriate / inappropriate ICD therapy | 12 months |
| Sensitivity for diagnosis of sustained VT | 12 months |
| Specificity for SVT diagnosis | 12 months |
| Quality of Life (MLHF Questionaire) | 12 months |
| Overall mortality | 12 months |
| Cardiac mortality | 12 months |
| Frequency and efficacy of ATP prior to / before capacitor charging in VF zone | 12 months |
| Amount of patients with appropriate / inappropriate shocks or ATP | 12 months |
| Altenburg |
| 04600 |
| Germany |
| Städtisches Krankenhaus St. Barbara Attendorn GmbH | Attendorn | 57439 | Germany |
| Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität | Bonn | 53127 | Germany |
| Klinikum Coburg | Coburg | 96450 | Germany |
| Evangelisches Krankenhaus Kalk | Cologne | 51103 | Germany |
| Klinik Fränkische Schweiz | Ebermannstadt | 91320 | Germany |
| Kreiskrankenhaus Ebersberg | Ebersberg | 85560 | Germany |
| Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang | Erfurt | 99084 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Krankenhaus Waltershausen-Friedrichroda | Friedrichroda | 99894 | Germany |
| Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen | Giessen | 35392 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Universitäres Herzzentrum Hamburg | Hamburg | 20246 | Germany |
| Oberhavel Kliniken GmbH Klinik Hennigsdorf | Henningsdorf | 16761 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | 24105 | Germany |
| Frankenwaldklinik Kronach GmbH | Kronach | 96317 | Germany |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH | Ludwigshafen | 67063 | Germany |
| St.-Marien-Hospital GmbH | Lünen | 44534 | Germany |
| Klinikum Memmingen | Memmingen | 87700 | Germany |
| Klinikum Großhadern der Ludwig-Maximilians-Universität München | München | 81377 | Germany |
| Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber | München | 81379 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Praxis Dres. med. Haggenmiller / Jeserich | Nuremberg | 90402 | Germany |
| Klinikum Nürnberg | Nuremberg | 90471 | Germany |
| Kreiskrankenhaus des Bördekreises Krankenhaus 4 | Oschersleben | 39387 | Germany |
| Niels-Stensen-Kliniken Marienhospital Osnabrück | Osnabrück | 49074 | Germany |
| Klinikum Pirna GmbH Klinik für Innere Medizin II | Pirna | 01796 | Germany |
| Klinikum Dorothea Christiane Erxleben GmbH | Quedlinburg | 06484 | Germany |
| Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes | Ratzeburg | 23909 | Germany |
| Universität Rostock | Rostock | 18057 | Germany |
| Katharinen-Hospital gGmbH | Unna | 59423 | Germany |
| Helios Klinikum Wuppertal | Wuppertal | 42117 | Germany |
| ID | Term |
|---|---|
| D003643 | Death |
| D016757 | Death, Sudden, Cardiac |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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