Using paced electrograms to improve ablation targeting for heart rhythm issues

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

This study is testing if a new method using paced electrograms can help doctors better target treatment for heart rhythm problems in patients with heart disease who have an implantable defibrillator.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Queen's University (Academic / other)
• Locations: 3 sites (Kingston, Ontario and 2 other locations)
• Trial ID: NCT03870854 on ClinicalTrials.gov

What this trial studies

This study investigates the use of Paced Electrogram Feature Analysis (PEFA) to identify specific sites for catheter ablation in patients with ischemic ventricular tachycardia. It is a multicenter prospective cohort study involving 40 patients who have ischemic heart disease and are equipped with an implantable cardioverter defibrillator (ICD). The goal is to reduce the occurrence of serious outcomes such as death, inappropriate ICD shocks, and sustained ventricular tachycardia by effectively targeting ablation sites. The study aims to compare the effectiveness of PEFA-guided ablation against existing data on standard care outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 with ischemic heart disease, a history of myocardial infarction, and who are eligible for catheter ablation.

Not a fit: Patients with severe heart failure symptoms, contraindications to heparin, or those with a limited life expectancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce life-threatening arrhythmias and improve the quality of life for patients with ischemic heart disease.

How similar studies have performed: While the use of PEFA in this context is innovative, similar studies have shown promise in improving ablation outcomes for ventricular tachycardia.

Eligibility criteria

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

Where this trial is running

Kingston, Ontario and 2 other locations

• Kingston Health Sciences Centre — Kingston, Ontario, Canada (Recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
• University of Ottawa Heart Institutation — Ottawa, Ontario, Canada (Not_yet_recruiting)

Study contacts

• Principal investigator: Damian Redfearn, MD — Queen's University
• Study coordinator: Dmitry Uchitel

Conditions Ischemic Ventricular Tachycardia