FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of VT Study

Study Overview
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Brief Summary
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This clinical investigation is intended to demonstrate the safety and effectiveness of ventricular ablation therapy using the FlexAbility Sensor Enabled Ablation Catheter in patients with drug-refractory monomorphic ventricular tachycardia in whom ventricular tachycardia recurs despite antiarrhythmic drug therapy or when antiarrhythmic drugs are not tolerated or desired.

Official Title
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FLExAbility Sensor Enabled Substrate Targeted Ablation for the Reduction of Ventricular Tachycardia (LESS-VT) Study

Conditions
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Ventricular Tachycardia

Intervention / Treatment
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* Device: Market Approved RF Ablation System
* Device: FlexAbility SE Ablation Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Structural heart disease (ischemic or non-ischemic) with one of the following: Confirmed diagnosis via echocardiography and/or cardiac CT/MRI, or Left ventricular ejection fraction (EF) <40% (documented within the last 6 months via echocardiography, or Arrhythmogenic RV cardiomyopathy/dysplasia (per 2010 ARVC/D Task Force Criteria).27 At least one documented episode of sustained MMVT by either EGM or ECG in the 6 months prior to enrollment Implanted with a market released ICD or CRT-D for at least 30 days prior to index ablation procedure Refractory (i.e. not effective, not tolerated or not desired) to at least one anti-arrhythmic medication (either amiodarone or sotalol) for treatment of MMVT At least 18 years of age 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. Able and willing to comply with all study requirements Exclusion Criteria: Implanted with a subcutaneous ICD Implanted with a ventricular assist device (VAD) (e.g. TandemHeart) Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO) Presence of intracardiac thrombus verified via computer tomography (CT), magnetic resonance imaging (MRI), transesophageal echocardiogram (TEE), or transthoracic echocardiogram (TTE) within 48 hours prior to the index ablation procedure or intra-procedure intracardiac echocardiography (ICE) o For subjects with a history of AF, this verification must be done via TEE or ICE ST elevation myocardial infarction (MI) within 60 days prior to index ablation procedure Previous cardiac surgery (e.g. ventriculotomy, atriotomy, coronary artery bypass graft), within 60 days prior to index ablation procedure Percutaneous coronary intervention (PCI) within 30 days prior to index ablation procedure Idiopathic VT Incessant VT (continuous sustained VT that promptly recurs despite repeated intervention for termination over ≥3 hours) necessitating immediate treatment or requiring hemodynamic support prior to the ablation procedure VT/VF thought to be from channelopathies Reversible cause of VT Severe aortic stenosis or flail mitral valve Mechanical mitral and aortic valve History of stroke with modified Rankin scale > 3 (See Appendix C) Unstable angina Chronic NYHA Class IV heart failure Ejection fraction < 15% Thrombocytopenia (defined as platelet count <80,000) or coagulopathy Contraindication to systemic anticoagulation (i.e. heparin, warfarin, or a direct thrombin inhibitor) Women who are pregnant or nursing Active uncontrolled infection Other anatomic or co morbid conditions or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the study or to comply with follow up requirements, or impact the scientific soundness of the study results Enrolled in an investigational study evaluating another device or drug that would confound the results of this study Have a life expectancy of less than 12 months due to any condition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pivotal medical device study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Randomized - Control<br> | Device: Market Approved RF Ablation System<br>* Subjects receive ablation using an FDA approved ablation system.<br>|
| Active Comparator: Randomized - Treatment<br> | Device: FlexAbility SE Ablation Catheter<br>* Subjects receive ablation treatment using an ablation system that is not FDA approved.<br>|
| Experimental: Non-randomized - Treatment<br> | Device: FlexAbility SE Ablation Catheter<br>* Subjects receive ablation treatment using an ablation system that is not FDA approved.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of complications | The primary safety endpoint is a composite of cardiovascular-related and procedure-related major complications through 7 days post index ablation procedure. | 7 days | 
| Freedom from recurrence of VT | The primary effectiveness endpoint is freedom from recurrent sustained MMVT at 6 months and a new or increased dose Class I or III AAD at 6 months following the index ablation procedure. | 6 months |