Status:
NOT_YET_RECRUITING
Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial
Lead Sponsor:
University of Arizona
Collaborating Sponsors:
Abbott
Conditions:
Sustained Monomorphic VT (MMVT)
Recurrent Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 tw...
Eligibility Criteria
Inclusion
- Criteria
- To participate in this clinical investigation, the subjects must meet all of the following 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):
- 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
- 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:
- 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).
- Limited life expectancy of 1 year or less.
- Presence of mitral and aortic valves both mechanical.
- Ventricular tachycardia secondary to electrolyte imbalance or any other reversible or non-cardiac cause.
- Severe aortic stenosis or flail mitral valve with severed mitral regurgitation.
- Thrombocytopenia (defined as platelet count \<50,000/μl ) or coagulopathy.
- Ventricular arrhythmias secondary to underlying channelopathies (LQTS, Brugada Syndrome).
- Enrolled in an investigational study evaluating another device or drug that would confound the results of this study.
- 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.
Exclusion
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2029
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06931821
Start Date
April 15 2025
End Date
April 30 2029
Last Update
April 17 2025
Active Locations (1)
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1
Banner University Medical Center Phoenix
Phoenix, Arizona, United States, 85006