Targeted Ablation to Isolate Scar Channels Causing Ventricular Tachycardia

Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease

The goal of this study is to map conducting channels within scar that cause ventricular tachycardia (VT) in patients with scar in their hearts in order to block these channels from causing VT with targeted radiofrequency ablation (cautery).

Participants undergoing VT ablation mapping of these channels by pacing many sites within the scar area and determining where these channels exit the scar into normal tissue. These exits will be ablated. Immediate success and success at 1 year will be evaluated.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Cardiomyopathy; Ventricular Tachycardia (VT); Nonischemic Cardiomyopathy
• Intervention / Treatment: Procedure: Selective Substrate Isolation

Detailed Description

After standard VT induction and mapping procedures (noninvasive identification of induced VT exit sites with Vektor vMap; substrate mapping; initial pacemapping), the study will consist of pacing within the substrate and mapping all channel exits both noninvasively with vMap as well as invasively with high density mapping catheters within the heart by escape mapping (all paced sites creating a consistent paced morphology, up to the shortest stimulus-to-QRS interval achieved) as well as focal activation mapping of this channel exit while pacing within the channel. The noninvasive map will aid in focusing invasive mapping to a small area of the substrate. Once the exit sites are determined, ablation energy will be delivered based on the mapped exit sites in the substrate channel within 0.5cm of the exit with the goal of blocking each exit site mapped. After the ablation lesion set is delivered, repeat attempt to induce VT will be performed. If more VT is induced, additional ablation energy will be delivered guided by standard mapping techniques (substrate, slow conduction zones, pacemapping).

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Westchester Medical Center
      • Sub-Investigator: Daniel Frenkel, MD
      • Contact: Jason T Jacobson, MD; Phone Number: 9144935314; Email: Jason.Jacobson@wmchealth.org
      • Contact: Sei Iwai, MD; Phone Number: 9149096900; Email: Sei.Iwai@wmchealth.org
      • Principal Investigator: Jason Jacobson, MD
      • Sub-Investigator: Sei Iwai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting to Westchester medical Center for ablation of VT with structural heart disease

Description

Inclusion Criteria:

• Patients with structural heart disease undergoing VT ablation

Exclusion Criteria:

1. Unable or unwilling to sign consent
2. Cardiogenic shock or NYHA Class IV heart failure and not a candidate for mechanical circulatory support for the procedure (percutaneous left ventricular assist device (LVAD), extracorporeal membrane oxygenation, or implanted LVAD)
3. Absence of substrate during initial voltage mapping

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants achieving substrate Isolation with ablation of exit sites	Inability to stimulate the ventricle (physiologic parameter) while pacing in the substrate area contained by the ablation lines through each pacemap exit, at sites that were able to stimulate the ventricle prior to ablation. This will be manifest by the absence of a QRS complex resultant from the pacing stimulus. This is a	Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VT invasive map exit and vMap exit match	Percent matching of VT exits determined by activation/entrainment/pace mapping for matched ECG morphologies with vMap determined exits	Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Channel exit and vMap match	Percent matching of noninvasively mapped exit sites compared with invasively mapped channel exits	Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Inducibility post initial ablation	VT inducibility after first lesion sets determined by channel mapping	Perioperative/Periprocedural: This will be measured during the study ablation procedure, after the first set of radiofrequency lesions is placed based in initial mapping.
1 year outcome	VT recurrence at 1 year determined by therapies delivered by implantable cardioverted defibrillator and presentation with sustained VT below ICD detection.	1 year: This will be measured for each subject up to 1 year after the study procedure.

Collaborators and Investigators

• Sponsor: New York Medical College

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2025
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 9, 2028

Study Registration Dates

• First Submitted: June 17, 2025
• First Submitted That Met QC Criteria: September 8, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 8, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: cardiomyopathy; Ventricular tachycardia; mapping; reentry; substrate; pacemapping
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Tachycardia; Pathological Conditions, Signs and Symptoms; Cardiomyopathies; Tachycardia, Ventricular
• Other Study ID Numbers: 23989

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No