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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
ICD implantation
Sponsored by
Astrakhan Federal Centre For Cardiac Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure With Reduced Ejection Fraction focused on measuring sudden cardiac death, heart failure, primary prevention, risk stratification

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Federal Center for Cardiovascular SurgeryRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ICD

Arm Description

ICD implanted

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of Cardiac Mortality
Registration of cardiac death
Number of Participants with CRT Response
Registration of CRT Response evaluated by transthoracic echocardiography

Full Information

First Posted
September 12, 2022
Last Updated
January 30, 2023
Sponsor
Astrakhan Federal Centre For Cardiac Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05539898
Brief Title
Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification
Acronym
PERFECT
Official Title
Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Stratification of the Risk of Stable Ventricular Tachyarrhythmias
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2017 (Actual)
Primary Completion Date
December 29, 2023 (Anticipated)
Study Completion Date
December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astrakhan Federal Centre For Cardiac Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction
Keywords
sudden cardiac death, heart failure, primary prevention, risk stratification

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICD
Arm Type
Other
Arm Description
ICD implanted
Intervention Type
Device
Intervention Name(s)
ICD implantation
Intervention Description
All included in the study will undergo ICD implantation for primary prevention of SCD
Primary Outcome Measure Information:
Title
Rate of VT primary occurrence
Description
A stable paroxysm of VT (lasting ≥ 30 seconds) detected in the "monitoring" zone of VT, or paroxysm of VT, requiring ICD therapy.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Rate of Cardiac Mortality
Description
Registration of cardiac death
Time Frame
24 months
Title
Number of Participants with CRT Response
Description
Registration of CRT Response evaluated by transthoracic echocardiography
Time Frame
24 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nikolay N Ilov, MD
Email
nikolay.ilov@gmail.com
Facility Information:
Facility Name
Federal Center for Cardiovascular Surgery
City
Astrakhan
State/Province
Astrakhan Region
ZIP/Postal Code
414000
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikolay Ilov, MD
Email
nikolay.ilov@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34112073
Citation
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.
Results Reference
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Improving the Criteria for Selecting Patients for Primary Prevention of Sudden Cardiac Death by Arrhythmic Risk Stratification

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