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

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 \[atrial fibrillation\], 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 \[ventricular tachycardia/ventricular fibrillation\] 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 \[New York Heart Association\] 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.