Recruiting

PEFA

Sponsor:

Dr. Damian Redfearn

Code:

NCT03870854

Conditions

Ischemic Ventricular Tachycardia (VT)

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

PEFA VT ablation technique

Study Details

Brief summary:

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

Conditions

Ischemic Ventricular Tachycardia (VT)

Study ID

NCT03870854

Start date

Aug 13, 2019

Status verified date

Nov, 2023

Completion date

Sep 30, 2025

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PEFA targeted substrate ablation

Use of PEFA strategy to identify and target VT isthmuses.

Interventions

PEFA VT ablation technique

Catheter ablation guided by PEFA technique

Primary outcome measure

  • All-cause mortality [ Time Frame: 3 years ]
  • Appropriate ICD shock [ Time Frame: 3 years ]
  • VT storm [ Time Frame: 3 years ]
  • Treated sustained VT below the detection rate of the ICD [ Time Frame: 3 years ]
  • Incessant VT [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Dmitry Uchitel

613-533-2148dmitry.uchitel@kingstonhsc.ca

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Contacts

Dmitry Uchitel

613-533-2148Dmitry.Uchitel@kingstonhsc.ca

KGHRI.CARU@kingstonhsc.ca

Principal Investigator:

Damian Redfearn

More Information

Sponsor

Dr. Damian Redfearn

Last update posted

Nov 15, 2023

Last verified

Nov, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. Damian Redfearn on 2023-11-15.