ILAM-guided VT ablation for sustained VT in adults with heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized study compares ILAM-guided VT ablation to conventional low-voltage mapping with extensive ablation. Participants have structural heart disease and recurrent MMVT despite at least one antiarrhythmic therapy. Both arms use high-density mapping with HD Grid catheters and irrigated ablation. The investigational arm targets deceleration zones identified by ILAM, while the control arm ablates low-voltage regions during sinus rhythm or pacing. The primary question is non-inferiority of the ILAM strategy compared with conventional voltage-based ablation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Banner University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting

Study contacts

• Principal investigator: Roderick Tung, MD — University of Arizona
• Study coordinator: Priyanka Sharma
• Email: priyankasharma1@arizona.edu
• Phone: 602-521-3090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.