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

NCT03713866 | Recruiting

• 1 other identifier: SAPP006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Tachycardia; Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• Termination of Ventricular Tachycardia

  The heart rhythm will be monitored continually with ECG electrodes to ascertain whether VT terminates with ablation.

  Less than 10 minutes post ablation

• VT recurrence rate

  Any recurring VT occurring within 6 months post procedure

  Less than 6 months post procedure

Study Arms (1)

EP Imaging and Testing

EXPERIMENTAL

MRI images,120 lead body surface mapping and NIPS testing will be completed to correlate areas of VT scar.

Diagnostic Test: EP Imaging and Testing

Interventions

EP Imaging and Testing DIAGNOSTIC_TEST

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.

EP Imaging and Testing

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have estimated Glomerular Filtration Ratio (eGFR) less than 30
• 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).

Sponsors & Collaborators

• John Sapp: lead
• Nova Scotia Health Authority: collaborator
• Rochester Institute of Technology: collaborator

Study Sites (1)

QEII HSC

Halifax, Nova Scotia, B3H 3A7, Canada

RECRUITING

MeSH Terms

Conditions

Tachycardia, Ventricular; Myocardial Infarction

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Study Officials

• John L Sapp, MD FRCPC

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John L Sapp, MD FRCPC

CONTACT

902 473 4272; john.sapp@nshealth.ca

Karen A Giddens

CONTACT

902 473 2758; karen.giddens@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Staff Cardiologist

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: November 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)