Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

Launched by UNIVERSITY OF ARIZONA · Apr 9, 2025

Keywords

ClinConnect Summary

The Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial is a clinical study designed to compare two different methods of treating a heart condition known as sustained monomorphic ventricular tachycardia (MMVT). This condition causes the heart to beat very quickly and can lead to serious health issues. The trial will test whether a new technique called ILAM, which focuses on specific areas of slow heart activity, is as effective as the traditional method that targets low voltage areas in the heart. Participants will be randomly assigned to one of the two treatment groups, and both groups will undergo mapping and ablation procedures using specialized catheters.

To be eligible for this study, participants must be at least 18 years old, have had at least one documented episode of MMVT in the past six months, and have heart issues that have not responded well to at least one anti-arrhythmic medication. Additionally, they should have evidence of heart damage, such as scarring, identified through imaging tests. If you join this trial, you'll receive careful monitoring and the opportunity to contribute to research aimed at improving treatment for this serious condition. It's important to understand that this study is not yet recruiting participants, so you may need to wait for it to begin if you're interested.

Gender

ALL

Eligibility criteria

• • 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.