Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia (PEFA-VT)

Canadian multicentre prospective cohort study of 40 patients with ischaemic heart disease and therapy from an implantable cardioverter defibrillator (ICD).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Ventricular Tachycardia (VT)
• Intervention / Treatment: Procedure: PEFA VT ablation technique

Detailed Description

Paced Electrogram Feature Analysis is employed to elucidate VT isthmus sites and target Type I sites for ablation to prevent recurrent VT/VF.

The trial hypothesis is: catheter ablation employing PEFA will, in comparison to published data, reduce the composite outcome of death at any time, appropriate ICD shock, ventricular tachycardia storm or treated sustained ventricular tachycardia below the detection rate of the ICD or incessant VT for patients with prior myocardial infarction and sustained ventricular tachycardia or fibrillation.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dmitry Uchitel; Phone Number: 613-533-2148; Email: Dmitry.Uchitel@kingstonhsc.ca

Study Locations

• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L 2V7
      • Recruiting
      • Kingston Health Sciences Centre
      • Contact: Dmitry Uchitel; Phone Number: 613-533-2148; Email: Dmitry.Uchitel@kingstonhsc.ca
      • Contact: Email: KGHRI.CARU@kingstonhsc.ca
      • Principal Investigator: Damian Redfearn
    • London, Ontario, Canada, N6A 5A5
      • Not yet recruiting
      • London Health Sciences Centre
      • Contact: Alexander Porretta, HBSc; Phone Number: 32268 519-685-8500; Email: Alexander.Porretta@lhsc.on.ca
      • Principal Investigator: Lorne Gula
    • Ottawa, Ontario, Canada
      • Not yet recruiting
      • University of Ottawa Heart Institutation
      • Contact: Madhuri Thommandru; Phone Number: 19080 613-696-7000; Email: mthommandru@ottawaheart.ca
      • Principal Investigator: Pablo Nery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• greater than 18 years of age
• Ischaemic heart disease and prior myocardial infarction (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury)
• Eligible for catheter ablation as standard of care
• Implantable Cardioverter Defibrillator

Exclusion Criteria:

• Unable or unwilling to provide consent
• Both mechanical aortic and mitral valve
• LV thrombus,
• NYHA class IV heart failure symptoms
• Contraindication to heparin
• Survival limited to <1 year in estimation of attending care team,
• Prior VT ablation Exclusion to standard of care VT catheter ablation procedure such as
• Active ischaemia (acute thrombus diagnosed by coronary angiography, or dynamic ST segment changes demonstrated on ECG) or another reversible cause of VT (e.g. drug- induced arrhythmia), had recent acute coronary syndrome within 30 days thought to be due to acute coronary arterial thrombosis, or have CCS functional class IV angina. Note that biomarker level elevation alone after ventricular arrhythmias does not denote acute coronary syndrome or active ischemia.
• Non-ischaemic cardiomyopathy because of reduced ablation success and PEFA has not been examined in the context of a non-ischaemic cardiomyopathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEFA targeted substrate ablation; Use of PEFA strategy to identify and target VT isthmuses.	Procedure: PEFA VT ablation technique; Catheter ablation guided by PEFA technique; Other Names: Paced electrogram feature analysis or 'PEFA'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	a composite of death - any time post procedure myocardial infarction and sustained ventricular tachycardia or fibrillation.	3 years
Appropriate ICD shock	Time to first appropriate ICD shock - any time post procedure	3 years
VT storm	Time to 3 or more episodes of VT within 24 hours - any time post procedure	3 years
Treated sustained VT below the detection rate of the ICD	Time to any sustained VT below the detection rate of the ICD; e.g. by external cardioversion, pharmacologic conversion, or manual ICD therapy - any time post procedure	3 years
Incessant VT	Time to incessant VT defined as a sustained ventricular arrhythmia which does not terminate despite appropriate external cardioversion/defibrillation or ICD antitachycardia pacing or shocks, or terminates but reinitiates within ≤5 seconds - any time post procedure	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appropriate anti-tachycardia pacing (ATP) from ICD	Appropriate anti-tachycardia pacing (ATP) from ICD - any time post procedure	3 years
Inducible for ventricular arrhythmia	Number of inducible for ventricular arrhythmia following catheter ablation guided by PEFA protocol	3 years
Number of ventricular arrhythmia events	This is a composite of appropriate ATP, appropriate shock, sustained VT not treated by ICD, external cardioversion, or pharmacologic cardioversion, and incessant VT - any time during or after the procedure	3 years
Escalation and De-escalation of antiarrhythmic medication	Any increase or decrease in the dosage of antiarrhythmic medication either due to inefficacy or side effects will be assessed - any time post procedure	3 years

Collaborators and Investigators

• Sponsor: Dr. Damian Redfearn
• Investigators: Principal Investigator: Damian Redfearn, MD, Queen's University

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: March 6, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ischemia; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: CTO-PA #1723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No