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

Not Applicable

Completed

• Conditions: Cardiac Death

• 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

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)

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

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

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