Clinical trial NCT01217528: Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients
Official title: Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Death
Keywords: ICD
CRTD
Sudden cardiac death
Device settings
Patients who received ICD/CRTD for primary prevention of sudden cardiac death
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2010-10-08
Enrollment: 543
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 prevention ICD indication.

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 concept for avoidance of inappropriate ICD therapy in patients who received the ICD for primary prevention of sudden cardiac death.

Eligibility criteria: Inclusion Criteria:

* Approved indication for new ICD implantation for primary prevention of sudden cardiac death
* Age \>=18 Years
* Written informed consent

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Primary Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: Amount of patients with appropriate / inappropriate ICD therapies
timeFrame: 12 months
measure: Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD
timeFrame: 12 months
measure: Number and cycle lengths of supraventricular / ventricular tachys
timeFrame: 12 months
measure: Time to first appropriate / inappropriate ICD therapy
timeFrame: 12 months
measure: Sensitivity for diagnosis of sustained VT
timeFrame: 12 months
measure: Specificity for SVT diagnosis
timeFrame: 12 months
measure: Quality of Life (MLHF Questionaire)
timeFrame: 12 months
measure: Overall mortality
timeFrame: 12 months
measure: Cardiac mortality
timeFrame: 12 months
measure: Frequency and efficacy of ATP prior to / before capacitor charging in VF zone
timeFrame: 12 months
measure: Amount of patients with appropriate / inappropriate shocks or ATP
timeFrame: 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Medizinische Einrichtungen der RWTH Aachen
city: Altenburg
country: Germany
facility: Klinikum Altenburger Land GmbH
city: Attendorn
country: Germany
facility: Städtisches Krankenhaus St. Barbara Attendorn GmbH
city: Bonn
country: Germany
facility: Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität
city: Coburg
country: Germany
facility: Klinikum Coburg
city: Ebermannstadt
country: Germany
facility: Klinik Fränkische Schweiz
city: Ebersberg
country: Germany
facility: Kreiskrankenhaus Ebersberg
city: Erfurt
country: Germany
facility: Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Friedrichroda
country: Germany
facility: Krankenhaus Waltershausen-Friedrichroda
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Henningsdorf
country: Germany
facility: Oberhavel Kliniken GmbH Klinik Hennigsdorf
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel
city: Kronach
country: Germany
facility: Frankenwaldklinik Kronach GmbH
city: Köln
country: Germany
facility: Evangelisches Krankenhaus Kalk
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Lünen
country: Germany
facility: St.-Marien-Hospital GmbH
city: Memmingen
country: Germany
facility: Klinikum Memmingen
city: München
country: Germany
facility: Klinikum Großhadern der Ludwig-Maximilians-Universität München
city: München
country: Germany
facility: Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Nürnberg
country: Germany
facility: Praxis Dres. med. Haggenmiller / Jeserich
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Oschersleben
country: Germany
facility: Kreiskrankenhaus des Bördekreises Krankenhaus 4
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück
city: Pirna
country: Germany
facility: Klinikum Pirna GmbH Klinik für Innere Medizin II
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben GmbH
city: Ratzeburg
country: Germany
facility: Wilhelm-Augusta Krankenhaus des Deutschen Roten Kreuzes
city: Rostock
country: Germany
facility: Universität Rostock
city: Unna
country: Germany
facility: Katharinen-Hospital gGmbH
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
Study officials:
affiliation: Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität Bonn
name: Jörg O Schwab, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.