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

Dr. Damian Redfearn

Status: Enrolling

Conditions: Ischemic Ventricular Tachycardia (VT)

Treatments: Procedure: PEFA VT ablation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03870854

CTO-PA #1723

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

PEFA targeted substrate ablation

Experimental group

Description:

Use of PEFA strategy to identify and target VT isthmuses.

Treatment:

Procedure: PEFA VT ablation technique