Cryoablation for Monomorphic Ventricular Tachycardia
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)
| Condition(s) | Sustained VT |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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) |
| Who can participate | Inclusion Criteria (IC): * 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% * Arrhythmogeni |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Adagio Medical |
| Locations | Phoenix, Arizona, United States; San Francisco, California, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States (+9 more sites) |
| Start date | 2023-09-11 |
| NCT ID | NCT05675865 |
| Official listing | https://clinicaltrials.gov/study/NCT05675865 |