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

Abbott Medical Devices543 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

543

Conditions

Cardiac Death

Interventions

device settings for group ADEVICE

VT zone: 350ms VF zone: 280ms

Device settings for group BDEVICE

VT zone: 320ms VF zone: 250ms

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (34)

Outcomes

Primary Outcomes

Primary Endpoint

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

Time frame: 12 months

Secondary Outcomes

Amount of patients with appropriate / inappropriate ICD therapies

Time frame: 12 months

Prevalence of slow VT (<=187bpm) in patients with indication for primary prevention of SCD

Time frame: 12 months

Number and cycle lengths of supraventricular / ventricular tachys

Time frame: 12 months

Time to first appropriate / inappropriate ICD therapy

Time frame: 12 months

Sensitivity for diagnosis of sustained VT

Time frame: 12 months

Specificity for SVT diagnosis

Time frame: 12 months

Quality of Life (MLHF Questionaire)

Time frame: 12 months

Overall mortality

Time frame: 12 months

Cardiac mortality

Time frame: 12 months

Frequency and efficacy of ATP prior to / before capacitor charging in VF zone

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 24 more locations