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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Reduction of Inappropriate ICD Therapies in Patients With Approved Indication for Primary Prevention of Sudden Cardiac Death

Conditions
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Cardiac Death

Intervention / Treatment
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* Device: device settings for group A
* Device: Device settings for group B


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Group A: VT zone: 350ms VF zone: 280ms | Device: device settings for group A<br>* VT zone: 350ms VF zone: 280ms<br>* Other names: Control group;|
| Experimental: Group B<br>Group B: VT zone: 320ms VF zone: 250ms | Device: Device settings for group B<br>* VT zone: 320ms VF zone: 250ms<br>* Other names: Treatment group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint | Event free survival of: inappropriate ICD therapies (only stored tachycardias with proper stored EGM documentation are taken into account) AND spontaneous, documented, sustained (>30s) ventricular tachycardia, that was not treated by the ICD | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRTD, Sudden cardiac death, Device settings, Patients who received ICD/CRTD for primary prevention of sudden cardiac death