NCT03713866 Peri-Procedural Transmural Electrophysiological (EP) Imaging of Scar-Related Ventricular Tachycardia
| NCT ID | NCT03713866 |
| Status | Recruiting |
| Phase | — |
| Sponsor | John Sapp |
| Condition | Ventricular Tachycardia |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2019-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2019-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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).
Contact & Investigator
John L Sapp, MD FRCPC
PRINCIPAL INVESTIGATOR
Nova Scotia Health Authority
Frequently Asked Questions
Who can join the NCT03713866 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Ventricular Tachycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03713866 currently recruiting?
Yes, NCT03713866 is actively recruiting participants. Contact the research team at john.sapp@nshealth.ca for enrollment information.
Where is the NCT03713866 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT03713866 clinical trial?
NCT03713866 is sponsored by John Sapp. The principal investigator is John L Sapp, MD FRCPC at Nova Scotia Health Authority. The trial plans to enroll 20 participants.