Ventricular Tachycardia (VT)NCT07814079
Targeted Ablation to Isolate Scar Channels Causing Ventricular Tachycardia
An observational study of Ventricular Tachycardia (VT) and Ischemic Cardiomyopathy, run by New York Medical College at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia (VT), Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy
- What is being tested?
- Selective Substrate Isolation
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2025to 9 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to Westchester medical Center for ablation of VT with structural heart disease
Who may be able to join
- Patients with structural heart disease undergoing VT ablation
Who cannot join
- Unable or unwilling to sign consent
- 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)
- Absence of substrate during initial voltage mapping
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Westchester Medical Center
Valhalla, New York, 10595
Jason T Jacobson, MD, 9144935314, Jason.Jacobson@wmchealth.org
Sei Iwai, MD, 9149096900, Sei.Iwai@wmchealth.org
About this study
Official title: 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.
Read the 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).
- Being tested
- Selective Substrate Isolation
- Keywords
- Ventricular tachycardia, substrate, mapping, reentry, cardiomyopathy, pacemapping
- Medical subject headings
- Tachycardia, Ventricular, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Substrate IsolationProcedure or surgery
Ablation will be guided by mapping the substrate "from the inside out" by identifying conducting channels as they might be activated during VT. Extensive pace mapping will be performed within scar areas identified during sinus rhythm mapping. The course of these channels will be identified and ablated across the distal portion, just proximal to the exit based on shortest stimulus-to-QRS interval obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 1 year: This will be measured for each subject up to 1 year after the study procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start27 Mar 2025
- Primary completion9 Dec 2027 (estimated)
- Study completion9 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Tachycardia (VT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814079
- Sponsor's protocol ID
- 23989
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Substrate Isolation for the Treatment of Ventricular Tachycardia in Patients With Structural Heart Disease
- ClinicalTrials.gov ID
- NCT07814079
- Acronym / sponsor ID
- 23989
- Keywords
- Ventricular tachycardia, substrate, mapping, reentry, cardiomyopathy, pacemapping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 9 Dec 2027 (estimated)
- Study completion
- 9 Dec 2028 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to Westchester medical Center for ablation of VT with structural heart disease
Key inclusion criteria (1 listed)
- Patients with structural heart disease undergoing VT ablation
Key exclusion criteria (3 listed)
- Unable or unwilling to sign consent
- 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)
- Absence of substrate during initial voltage mapping
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selective Substrate IsolationAblation will be guided by mapping the substrate "from the inside out" by identifying conducting channels as they might be activated during VT. Extensive pace mapping will be performed within scar areas identified during sinus rhythm mapping. The course of these channels will be identified and ablated across the distal portion, just proximal to the exit based on shortest stimulus-to-QRS interval obtained. | Procedure or surgery | – |
Primary outcome
Number of participants achieving substrate Isolation with ablation of exit sites
Time frame: Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.
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
4 secondary outcomes
VT invasive map exit and vMap exit match
Time frame: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Channel exit and vMap match
Time frame: Perioperative/Periprocedural: This will be measured throughout the study ablation procedure.
Inducibility post initial ablation
Time frame: 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
Time frame: 1 year: This will be measured for each subject up to 1 year after the study procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia (VT) and Ischemic Cardiomyopathy, run by New York Medical College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving substrate Isolation with ablation of exit sites (time frame: Perioperative/Periprocedural: This will be measured at the end of the study ablation procedure only.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.