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

Not Applicable

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction
• Interventions: Device: ICD implantation

• Registration Number: NCT05539898
• Lead Sponsor: Astrakhan Federal Centre For Cardiac Surgery

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-13
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Study First Posted: 2022-09-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01
• Primary Completion: 2023-12-29
• Study Completion: 2024-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICD	ICD implantation	ICD implanted

Primary Outcome Measures

Name	Time	Method
Rate of VT primary occurrence	24 months	A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.

Secondary Outcome Measures

Name	Time	Method
Rate of Cardiac Mortality	24 months	Registration of cardiac death
Number of Participants with CRT Response	24 months	Registration of CRT Response evaluated by transthoracic echocardiography

Trial Locations

Locations (1)

Federal Center for Cardiovascular Surgery; 🇷🇺 Astrakhan, Astrakhan Region, Russian Federation