RecruitingVentricular Tachycardia, SustainedVentricular Tachycardia, Monomorphic
Cryoablation for Monomorphic Ventricular Tachycardia (VTS)
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)
Sponsor: Adagio Medical
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ EC 1 Intracardiac thrombus by TTE or TEE within 48 hours prior to the procedure
- ✕ EC 2 Presence of isolated epicardial scar(s) requiring epicardial ablation identified by either preoperative CMR imaging within 90 days of procedure or intra-procedurally using EAM and PES prior to investigational device use
- ✕ EC 3 VTs due to any of the following causes:
- ✕ 1. Idiopathic VT
- ✕ 2. Automaticity or triggered activity
- ✕ 3. Bundle Branch Reentry (BBR)
- ✕ 4. Any focal tachycardia (e.g., papillary, RVOT)
- ✕ 5. Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
Where it's recruiting
Arizona
Phoenix
California
Long Beach
Massachusetts
Boston
New York
Staten Island
Pennsylvania
Philadelphia
South Carolina
Charleston
Tennessee
Nashville
Virginia
Richmond
Source: ClinicalTrials.gov · NCT07650032 · last updated 2026-08-12