Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification

Study Overview
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Brief Summary
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A number of large randomized studies have demonstrated the importance of left ventricle ejection fraction (LV EF) for ventrucular tachyarhrythmia's (VT) prediction. The use of this indicator as the sole predictor of high arrhythmic risk requiring ICD implantation is enshrined in the current clinical recommendations. At the same time, many experts consider LV EF as too generalized indicator, which can be an integral indicator of total cardiovascular mortality, but lacks specificity in determining the risk of VT. It is known that only about 20% of patients with ICD implanted for primary prevention of sudden cardiac death (SCD) receive appropriate life-saving therapy. Purpose of the study: to develop additional criteria for selection of patients with heart failure for implantation of cardioverter-defibrillator for the purpose of primary SCD prevention on the basis of stratification of the risk of occurrence of stable ventricular tachyarrhythmias.

Official Title
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Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias

Conditions
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Heart Failure With Reduced Ejection Fraction

Intervention / Treatment
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* Device: ICD implantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: LV EF ≤ 35% inspite of optimal drug therapy of heart failure (3 months and longer) NYHA II-IV favorable prediction of survival for 1 year or more Exclusion Criteria: secondary SCD prevention indications for open heart surgery hypertrophic cardiomyopathy arrhythmogenic right ventricular dysplasia genetic channelopathies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ICD<br>ICD implanted | Device: ICD implantation<br>* All included in the study will undergo ICD implantation for primary prevention of SCD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of VT primary occurrence | A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the monitoring zone of VT, or paroxysm of VT, requiring ICD therapy. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Cardiac Mortality | Registration of cardiac death | 24 months | 
| Number of Participants with CRT Response | Registration of CRT Response evaluated by transthoracic echocardiography | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sudden cardiac death, heart failure, primary prevention, risk stratification