Functional ElectroAnatomiC Isochronal Late Activation Mapping for Empiric VT Ablation Trial

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.