Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial (NCT06931821) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
United States360 participantsStarted 2025-04-15
Plain-language summary
This is a multicenter, prospective, parallel, randomized controlled trial to test for non-inferiority with an ILAM-guided VT ablation compared to conventional voltage- based ablation. The study has two treatment arms: conventional voltage mapping and ablation (control arm). In the investigational arm, the ablation strategy is guided by ILAM to target deceleration zones, blinded to voltage mapping. In the control arm, ablation will be performed to extensively ablate all low voltage regions (\<1.5mV) during sinus rhythm, right ventricular (RV) pacing, or left ventricular (LV) pacing, with discretionary use of pacemapping and activation mapping. In both arms, mapping with be performed with a multielectrode catheter (HD Grid) and ablation will be performed using an irrigated tip catheter (FlexAbility SE or Tactiflex catheters).
In the control armonly voltage mapping displays will be utilized (blinded to functional ILAM and fractionation). High density mapping with automated last deflection annotation (Ensite X) will be performed in all patients randomized to ILAM approach during either sinus rhythm or RV pacing.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient is ≥18 years of age.
. Able and willing to comply with all study requirements.
. At least one documented episode of sustained MMVT (\>30 sec) by either EGM or ECG (including Holter, or loop recorder) in the 6 months prior to enrollment.
. Informed of the nature of the study, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical study site.
. Refractory (i.e., not effective, not tolerated, or not desired) to at least one anti-arrhythmic medication (including, but not limited to beta blocker, mexiletine, amiodarone or sotalol) for treatment of MMVT.
. Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c):
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inducibility for VT
Timeframe: after initial 25 minutes of ablation (minutes of radiofrequency)
2
Recurrent VT
Timeframe: 1 year post procedure
3
CV Hospitalization
Timeframe: 1 year post procedure
4
Mortality
Timeframe: 1 year post procedure
5
Procedure Related Safety
Timeframe: Duration of Hospitalization (up to 7 days)
. Evidence of myocardial scar by echocardiography (segmental wall motion or wall thinning), CT (wall thinning) and/or MRI (presence of delayed enhancement /late gadolinium enhancement) . CT or MRI with scar is mandatory for inclusion of NICM., or
. Left ventricular ejection fraction (EF) \<50% \[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\] with presence of scar, or
Exclusion criteria
. Active infection (positive blood culture).
. Patient is pregnant or nursing.
. Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment.
. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor).
. Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD).
. Left Ventriclar ejection fraction \< 15%.
. Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment.
. Idiopathic VT or preprocedural imaging without scar (MRI or CT).