Cryoablation for Monomorphic Ventricular Tachycardia Early Feasibility Study (EFS)

The objective of this clinical study is to evaluate the safety and performance of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic VT (SMVT)

Inclusion Criteria (IC):IC 1 Male or female ≥ 18 yearsIC 2 Patients with a clinical indication for a catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained monomorphic Ventricular TachycardiaIC 3 Has received an ICD prior to enrollmentIC 4 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 monthsIC 5 Refractory to, or intolerant of, at least one Class III AADIC 6 Subject has LVEF ≥ 20%, confirmed by echo or comparable technique during baseline evaluation or in the previous three monthsIC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the studyIC 8 Willingness and ability to give an informed consentExclusion Criteria (EC):EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedureEC 2 Idiopathic VTEC 3 Any VT ablation within 4 weeks prior to enrollmentEC 4 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 yearsEC 5 Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac causeEC 6 Cardiogenic shock, unless it is due to incessant monomorphic VTEC 7 Structural heart disease as described below:Class IV heart failureAortic aneurysmPrevious cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedureInteratrial baffle, closure device, patch, or PFO occlusion deviceCoronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedureAcute MI or unstable angina in the previous 60 daysMechanical mitral or aortic valveSevere Mitral or Aortic insufficiency or stenosis based on most recent TTECardiac myxomaSignificant congenital heart diseaseEC 8 Acute illness or active systemic infectionEC 9 Any previous history of cryoglobulinemiaEC 10 History of blood clotting or bleeding diseaseEC 11 Peripheral vascular disease that precludes LV accessEC 12 Contraindication to heparinEC 13 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedureEC 14 Any prior history of documented cerebral vascular accident (CVA), TIA or systemic embolism (excluding a post-operative Deep Vein Thrombosis, DVT), within 6 months prior to the ablation procedure.EC 15 Pregnant, or anticipated pregnancy during study follow-upEC 16 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this studyEC 17 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, candidate for heart transplantation, patient with ventricular assist device, or terminal illness with a life expectancy less than 12 months)