NCT05539898

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Astrakhan Federal Centre For Cardiac Surgery · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
DEVICE	ICD implantation	All included in the study will undergo ICD implantation for primary prevention of SCD

Timeline

• Start date: 2017-01-13
• Primary completion: 2023-12-29
• Completion: 2024-12-29
• First posted: 2022-09-14
• Last updated: 2023-02-01

Locations

1 site across 1 country: Russia