Clinical trial NCT03870854: Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
Official title: Paced Electrogram Feature Analysis (PEFA) for Ablation Targeting in Ischaemic Ventricular Tachycardia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ischemic Ventricular Tachycardia (VT)
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a Canadian multi-centre prospective cohort study of 40 participants.
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 years
measure: Appropriate ICD shock
timeFrame: 3 years
measure: VT storm
timeFrame: 3 years
measure: Treated sustained VT below the detection rate of the ICD
timeFrame: 3 years
measure: Incessant VT
timeFrame: 3 years
Secondary outcomes:
measure: Appropriate anti-tachycardia pacing (ATP) from ICD
timeFrame: 3 years
measure: Inducible for ventricular arrhythmia
timeFrame: 3 years
measure: Number of ventricular arrhythmia events
timeFrame: 3 years
measure: Escalation and De-escalation of antiarrhythmic medication
timeFrame: 3 years
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institutation
state: Ontario
Study officials:
affiliation: Queen's University
name: Damian Redfearn, MD
role: PRINCIPAL_INVESTIGATOR
References: