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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-13

Study Completion Date

2024-12-29

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.

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Detailed Description

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Conditions

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Heart Failure With Reduced Ejection Fraction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ICD

ICD implanted

Group Type OTHER

ICD implantation

Intervention Type DEVICE

All included in the study will undergo ICD implantation for primary prevention of SCD

Interventions

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ICD implantation

All included in the study will undergo ICD implantation for primary prevention of SCD

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No