Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

Study Overview
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Brief Summary
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The purpose of this clinical investigation is the continued assessment of the decision accuracy of St. Jude Medical (SJM) ICD with enhanced SVT discriminators in the treatment of subjects with primary and secondary prevention of sudden cardiac death.

Detailed Description
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With Ellipse™ and Fortify Assura™ ICD family, St. Jude Medical introduced enhanced device algorithms that may be helpful to further improve SVT discrimination success: SecureSense™, Far field morphology, Chamber Onset. These algorithms in combination with a tailored device setting (primary or secondary prevention) will be prospectively investigated within this trial.

Official Title
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Reduction of Inappropriate Shocks of Implantable Cardioverter Defibrillators (ICDs) With Enhanced SVT Discriminators

Conditions
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Tachycardia

Intervention / Treatment
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* Device: ICD with enhanced SVT discriminators


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic or nonischemic cardiomyopathy Primary prevention or secondary prevention of Sudden cardiac death (SCD) Indication for ICD/CRT-D new implantation per current guidelines (1, 2, 3-chamber) The patient is ≥ 18 years of age The patient is able to understand the patient information and is capable to provide informed consent. The patient has provided written informed consent prior to any investigational related procedure Exclusion Criteria: Previously implanted ICD/CRT-D Hypertrophic (with or without obstructive) cardiomyopathy Ion channel disorders (Long/Short-QT, Brugada syndrome etc…) New York Heart Association (NYHA) Class IV Recent cardiac decompensation (within previous 3 months) The patient is unable to comply with the follow up schedule. The patient is participating in another investigational device or drug investigation. The patient is pregnant or is planning to become pregnant during the duration of the investigation

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Enhanced SVT discriminators<br>Patients with activated enhanced SVT discriminators (in accordance with predefined mandatory study settings) | Device: ICD with enhanced SVT discriminators<br>* ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.<br>* Other names: Unify Assura (St. Jude Medical);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inappropriate ICD shocks | Freedom from inappropriate automatically delivered ICD-shocks within 12 months Follow-Up (FU) period after ICD/CRT-D implantation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICD shocks for any reason | Freedom from automatically delivered ICD shocks for any reason during FU period | 12 months | 
| Inappropriate ICD therapies | Freedom from automatically delivered inappropriate ICD therapies during FU period | 12 months | 
| Untreated VT/VF | Freedom from untreated sustained ventricular tachycardia (VT) / ventricular fibrillation (VF) during FU period | 12 months | 
| Accuracy of ICD therapy decision | Accuracy of ICD therapy decision (VT/VF and nonVT/VF) | 12 months | 
| Specificity | Specificity for… … other than sustained VT/VF … SVT (Supraventricular tachycardia) … different subtypes of SVTs (Sinus Tachycardia, Atrial Fibrillation, Atrial Flutter, other SVT). | 12 months | 
| Cardiac deaths | Cardiac deaths | 12 months | 
| Sensitivity | Sensitivity for sustained VT/VF | 12 months | 
| ICD/CRT-D related SAE | ICD/CRT-D related Serious Adverse Events (SAE) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICD, CRT-D, Sudden cardiac death, Device settings, Optimized programming strategy