Reduction of Inappropriate Implantable Cardioverter Defibrillator (ICD) Therapies in Primary Prevention Patients

Not Applicable

Completed

• Conditions: Cardiac Death
• Interventions: Device: device settings for group A; Device: Device settings for group B

• Registration Number: NCT01217528
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2010-09-10
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 543

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	device settings for group A	Group A: * VT zone: 350ms * VF zone: 280ms
Group B	Device settings for group B	Group B: * VT zone: 320ms * VF zone: 250ms

Primary Outcome Measures

Name	Time	Method
Primary Endpoint	12 months	Event free survival of: 1. inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND; 2. spontaneous, documented, sustained (\>30s) ventricular tachycardia, that was not treated by the ICD

Secondary Outcome Measures

Name	Time	Method
Amount of patients with appropriate / inappropriate ICD therapies	12 months
Specificity for SVT diagnosis	12 months
Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD	12 months
Time to first appropriate / inappropriate ICD therapy	12 months
Cardiac mortality	12 months
Number and cycle lengths of supraventricular / ventricular tachys	12 months
Sensitivity for diagnosis of sustained VT	12 months
Quality of Life (MLHF Questionaire)	12 months
Overall 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

Trial Locations

Locations (34)

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Universitätsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

St.-Marien-Hospital GmbH; 🇩🇪 Lünen, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Oberhavel Kliniken GmbH Klinik Hennigsdorf; 🇩🇪 Henningsdorf, Germany

Frankenwaldklinik Kronach GmbH; 🇩🇪 Kronach, Germany

Evangelisches Krankenhaus Kalk; 🇩🇪 Köln, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; 🇩🇪 Ludwigshafen, Germany

Medizinische Einrichtungen der RWTH Aachen; 🇩🇪 Aachen, Germany

Städtisches Krankenhaus St. Barbara Attendorn GmbH; 🇩🇪 Attendorn, Germany

Klinikum Altenburger Land GmbH; 🇩🇪 Altenburg, Germany

Medizinische Einrichtungen der Rheinischen Friedrich-Wilhelm-Universität; 🇩🇪 Bonn, Germany

Klinikum Coburg; 🇩🇪 Coburg, Germany

Klinik Fränkische Schweiz; 🇩🇪 Ebermannstadt, Germany

Kreiskrankenhaus Ebersberg; 🇩🇪 Ebersberg, Germany

Kardiologische Gem.-Praxis Dres. med. Bischoff / Lang; 🇩🇪 Erfurt, Germany

Klinikum Esslingen; 🇩🇪 Esslingen, Germany

Universitätsklinik Freiburg; 🇩🇪 Freiburg, Germany

Krankenhaus Waltershausen-Friedrichroda; 🇩🇪 Friedrichroda, Germany

Universitätsklinikum Gießen und Marburg GmbH - Standort Gießen; 🇩🇪 Gießen, Germany

Klinikum Memmingen; 🇩🇪 Memmingen, Germany

Klinikum Großhadern der Ludwig-Maximilians-Universität München; 🇩🇪 München, Germany

Herzkatheter / Praxisklinik Dres. med. Mühling / Prof. Dr. Silber; 🇩🇪 München, Germany

Praxis Dres. med. Haggenmiller / Jeserich; 🇩🇪 Nürnberg, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, 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

Helios Klinikum Wuppertal; 🇩🇪 Wuppertal, Germany

Katharinen-Hospital gGmbH; 🇩🇪 Unna, Germany

Universitätsklinikum Münster; 🇩🇪 Münster, Germany