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

NCT05539898 | Unknown

• 1 other identifier: ONRS_01
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

sudden cardiac death; heart failure; primary prevention; risk stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of Cardiac Mortality

  24 months

• Number of Participants with CRT Response

  24 months

Study Arms (1)

ICD

OTHER

ICD implanted

Device: ICD implantation

Interventions

ICD implantation DEVICE

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

ICD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• secondary SCD prevention
• indications for open heart surgery
• hypertrophic cardiomyopathy
• arrhythmogenic right ventricular dysplasia
• genetic channelopathies

Sponsors & Collaborators

• Astrakhan Federal Centre For Cardiac Surgery: lead

Study Sites (1)

Federal Center for Cardiovascular Surgery

Astrakhan, Astrakhan Oblast, 414000, Russia

RECRUITING

Related Publications (1)

• Ilov NN, Palnikova OV, Stompel DR, Nechepurenko capital A, CyrillicA. Clinical Predictors of Occurrence of Ventricular Tachyarrhythmias in Patients with Reduced Left Ventricle Ejection Fraction. Results of Single-Center Prospective Study. Kardiologiia. 2021 May 31;61(5):32-40. doi: 10.18087/cardio.2021.5.n1480. English, Russian.

  PMID: 34112073 RESULT

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nikolay N Ilov, MD

CONTACT

nikolay.ilov@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: January 13, 2017
• Primary Completion: December 29, 2023
• Study Completion: December 29, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)