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Clinical Trials in Canada / NCT03713866
Recruiting Not applicable

Peri-Procedural Transmural Electrophysiological (EP) Imaging of Scar-Related Ventricular Tachycardia

NCT03713866 · tracked via the Priya Life Science Canada tracker
Sponsor
John Sapp
Phase
Not applicable
Started
2019-11-01
Last updated
2026-03-17

Condition(s) studied

Ventricular TachycardiaMyocardial Infarction

Investigational drug(s) / intervention(s)

EP Imaging and Testing

EP Imaging and Testing: Magnetic Resonance Imaging: pre-procedure imaging is standard care prior to catheter ablation procedures for VT to document anatomy of the heart. 120-Lead Body Surface Mapping: a 120-lead ECG will be recorded using a standardized mapping protocol. 120 disposable radiolucent silver chloride (Ag/AgCl) surface electrodes will be placed on the torso in 18 strips and connected via cables to an advanced acquisition system. Noninvasive programmed stimulation (NIPS) study will be performed using the patient's implanted defibrillator, and is part of standard practice during a VT catheter ablation.

Study summary

Ventricular tachycardia (VT) contributes to over 350,000 sudden deaths each year in the US. Malignant VTs involve an electrical "short circuit" in the heart, formed by narrow channels of surviving tissue inside myocardial scar. An important treatment is to use catheter ablation to "block" the channel that forms the circuit. Effective ablation requires imaging guidance to visualize the VT circuit relative to scar structures in 3D. Unfortunately, with conventional catheter mapping, up to 90% of the VT circuits are too short-lived to be mapped. For the 10% "mappable" VTs, their data are only available during ablation and limited to one ventricular surface. This inadequacy of functional VT data largely limits the knowledge about scar-related VT and ablation strategies, and reduces the ability of clinicians to identify ablation targets and assess ablation outcome.

The central hypothesis of this proposal is that functional VT data, integrated with CT or MRI scar data in 3D, can improve VT ablation efficacy with pre-procedural identification of ablation targets and post-procedural mechanistic elucidation of ablation failure. This research builds on the rapidly increasing clinical interest in electrocardiographic imaging (ECGi), an emerging technique that obtains cardiac electrical activity through inverse reconstructions from ECGs. The specific objective is to push the boundary of ECGi to provide - as a conjunction to intra-procedural catheter mapping - pre-ablation and post-ablation imaging of functional VT circuits integrated with 3D scar structure.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * One or more episodes of sustained monomorphic VT * Referred for catheter ablation * Previously implanted ICD * Signed the patient informed consent form * Able and willing to comply with all pre-, post-, and follow-up testing and requirements Exclusion Criteria: * Have estimated Glomerular Filtration Ratio (eGFR) less than 30 * Have a life expectancy less than 6 months or are listed for heart transplantation at time of inclusion * Are pregnant * Are on IV inotropic agents * Have any contraindication to catheter ablation (including but not limited to mechanical prosthetic aortic and mitral valves, known protruding Left Ventricular (LV) thrombus * New York Heart Association (NYHA) functional class IV * Had ST wave elevation myocardial infarction within \< 1 month * Unwilling or unable to undergo cardiac MRI scan AND unwilling or unable to undergo cardiac CT scan (e.g. contrast allergy).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
QEII HSC Halifax Nova Scotia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03713866 on ClinicalTrials.gov ↗ ← All trials in Canada