Recruiting

Electrophysiological Imaging

Sponsor:

John Sapp

Code:

NCT03713866

Conditions

Ventricular Tachycardia

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

EP Imaging and Testing

Study Details

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

Study ID

NCT03713866

Start date

Nov 1, 2019

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: EP Imaging and Testing

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

Interventions

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.

Primary outcome measure

  • Termination of Ventricular Tachycardia [ Time Frame: Less than 10 minutes post ablation ]
  • VT recurrence rate [ Time Frame: Less than 6 months post procedure ]

Central Contacts and Locations

Central contacts

Locations

QEII HSC

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Contacts

More Information

Sponsor

John Sapp

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Sapp on 2026-03-17.