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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05539898

Acronym

PERFECT

Enrollment

450

Registered

2022-09-14

Start date

2017-01-13

Completion date

2024-12-29

Last updated

2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Reduced Ejection Fraction

Keywords

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

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.

Interventions

DEVICEICD implantation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Russia

Contacts

Primary ContactNikolay N Ilov, MD

nikolay.ilov@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026