Can a smarter heart map make risky ablation safer and more effective?
NCT ID NCT06931821
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This trial compares two ways to guide ablation for ventricular tachycardia, a dangerous fast heart rhythm. One method uses standard voltage mapping to burn away all low-voltage scar tissue. The other uses a newer technique called ILAM that targets specific zones where the electrical signal slows down. The goal is to see if the ILAM-guided approach is at least as good as the standard method, with fewer complications and less heart damage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Isochronal Late Activation Mapping (ILAM) guided ablation using a standard irrigated tip catheter
- What this could lead to
- If successful, this approach could make heart ablation more precise, reducing the need for repeat procedures and lowering complication rates.
- What could go wrong
- This is a non-inferiority trial, so the new method may prove no better than the current standard. The technique is also highly specialized, which may limit generalizability.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Criteria To participate in this clinical investigation, the subjects must meet all of the following inclusion criteria: 1. Patient is ≥18 years of age. 2. Able and willing to comply with all study requirements. 3. 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. 4. 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. 5. 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. 6. Structural heart disease (ischemic or non-ischemic) with one of the following (a, b or c): 1. 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 2. Left ventricular ejection fraction (EF) \<50% \[documented within the last 6 months via transthoracic echocardiogram (TTE), MRI\] with presence of scar, or 3. Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria) Exclusion Criteria Subjects who meet any of the following exclusion criteria must be excluded from the clinical investigation: 1. Active infection (positive blood culture). 2. Patient is pregnant or nursing. 3. Cardiac surgery via sternotomy (CABG or valve repair/replacement) within 30 days prior to enrollment. 4. Contraindication to systemic anticoagulation (i.e., heparin, warfarin, or a direct thrombin inhibitor). 5. Currently receiving support via extracorporeal membrane oxygenation (ECMO) or ventricular assist device (VAD). 6. Left Ventriclar ejection fraction \< 15%. 7. Stroke within 30 days or presence of LV thrombus within 1 month prior to enrollment. 8. Idiopathic VT or preprocedural imaging without scar (MRI or CT). 9. Limited life expectancy of 1 year or less. 10. Presence of mitral and aortic valves both mechanical. 11. Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause. 12. Severe aortic stenosis or flail mitral valve with severed mitral regurgitation. 13. Thrombocytopenia (defined as platelet count \<50,000/μl ) or coagulopathy. 14. Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome). 15. Enrolled in an investigational study evaluating another device or drug that would confound the results of this study. 16. Other anatomic or co-morbid conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirement of 1 year, or impact the scientific integrity of the study results.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Banner University Medical Center Phoenix
RECRUITINGPhoenix, Arizona, 85006, United States
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