Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications

Study Overview
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Brief Summary
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The aim of the study is to assess the negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.

Official Title
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Predictive Risk Stratification Through T Variability in ICD Patients Without Pacing Indications

Conditions
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Sudden Cardiac Death

Intervention / Treatment
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* Device: Ovatio VR 6250 or DR6550


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has been prescribed the implantation of an SORIN GROUP OvatioTM DR 6550 / VR 6250 system according to relevant currently-approved guidelines CHF since > 3 months and LVEF < 35% and NYHA class II or III OR Prior Myocardial infarction since more than 4 weeks and LVEF < 30% Exclusion Criteria: Documented spontaneous sustained ventricular tachycardia Prior implant of any device for ventricular cardiac pacing Existing indication for permanent ventricular pacing Myocardial infarction within 4 weeks prior to enrollment Arrhythmogenic RV-Dysplasia Brugada syndrome Long QT syndrome Performed within 3 months prior to enrollment or scheduled (within 3 months) cardiac revascularization (interventional or surgical) Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system. Excisting or planned administration of amiodarone - initiation of amiodarone therapy during the run of the study will lead to immediate exclusion of the patient Permanent chronic atrial fibrillation / flutter Patient is unable to attend the scheduled follow-up visits at the participating centre Patient is already included in another ongoing clinical study Patient is unable to understand the objectives of the study Patient refuses to cooperate Patient is unable or refuses to provide informed consent Patient is minor (less than 18-year old) Patient has life expectancy of less than 1 year Patient is pregnant.
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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Ovatio VR 6250 or DR6550<br>* The study requires the implantation of locally approved material: A right ventricular defibrillation lead In case of use of a dual chamber ICD a right atrial pacing lead A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study. Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAV score and number of tachyarrhythmic events. |  | The two phases M0 - M12 and M12 - M24 will be examined separately. For each 12 months period the TAV score at its beginning and tachyarrhythmic events in the following 12 months will be assessed. The NPV will be calculated for both phases. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TAV change |  | 12 months of follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Risk stratification method, negative predictive value, fast ventricular arrhythmias, ICD, The negative predictive value of the T amplitude variance as a method for risk stratification for patients with an increased risk for SCD.