Cryoablation for Monomorphic Ventricular Tachycardia IDE Study: EFS and Pivotal
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
• IC 1 Male or female ≥ 18 years
• IC 2 Patients with a clinical indication for catheter ablation due to ischemic and/or non-ischemic heart disease and recurrent symptomatic sustained scar-mediated monomorphic Ventricular Tachycardia.
• IC 3 Any of the following:
‣ Ischemic cardiomyopapthy (ICM) patients with prior history of myocardial infarction with Q waves, focal wall motion abnormality on imaging, fixed perfusion defect correlating with coronary stenosis or prior coronary intervention, 20% ≤ LVEF \< 50%.
⁃ non-ischemic cardiomyopathy (NICM) patients with scar in a territory without coronary stenosis as evidenced by CMR imaging within the prior 90 days or intra-procedurally using EAM and PES prior to investigational device use, 20% ≤ LVEF \< 50%
⁃ Arrhythmogenic right ventricular cardiomyopathy (ARVC)
• IC 4 Has received a market-released ICD prior to enrollment
• IC 5 Patient has had at least 1 documented spontaneous episode of SMVT within the previous 6 months
• IC 6 Refractory to, or intolerant of, at least one Class III AAD. (Refractory or intolerant defined as AAD failure due to recurrent VT, not tolerated/ desired due to side effects)
• IC 7 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
• IC 8 Willingness and ability to give an informed consent