Cryoablation for Monomorphic Ventricular Tachycardia (VTS)

Starting soon · Not applicable

Conditions studied: Ventricular Tachycardia, Sustained, Ventricular Tachycardia, Monomorphic

In brief

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)

Key facts

Study ID

NCT07650032

Run by

Adagio Medical

People needed

100

Starts

2026-08-01

Expected to finish

2027-09-30

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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:
• Idiopathic VT
• Automaticity or triggered activity
• Bundle Branch Reentry (BBR)
• Any focal tachycardia (e.g., papillary, RVOT)
• Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
• EC 4 NICM patients only, if any of the following apply:
• Congenital condition that limits access to the left or right ventricles
• Severe aortic or mitral stenosis, severe mitral regurgitation, or severe aortic insufficiency
• Active inflammatory processes (e.g., myocarditis) within the past 120 days
• Sarcoidosis
• Hypertrophic cardiomyopathy
• Drug- or alcohol-induced cardiomyopathy
• EC 5 Any VT ablation within 4 weeks prior to enrollment
• EC 6 More than one prior (>4 weeks) VT ablation or prior surgical treatment for VT within the past 2 years
• EC 7 Cardiogenic shock, unless it is due to incessant monomorphic VT
• EC 8 Any other cardiovascular conditions as described below:
• Class IV heart failure
• Aortic aneurysm
• Previous cardiac surgery or percutaneous coronary intervention within 60 days prior to index procedure
• Interatrial baffle, closure device, patch, or PFO occlusion device
• Coronary artery bypass graft (CABG) procedure within six (6) months prior to the ablation procedure
• Acute MI or unstable angina in the previous 60 days

Where it is running

• Banner University Medical Center Phoenix — Phoenix, Arizona, United States
• MemorialCare Long Beach Medical Center — Long Beach, California, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Northwell Health- Staten Island University Hospital — Staten Island, New York, United States
• Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical Center of South Carolina (MUSC) — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• McGill University Health Centre (MUHC), Montreal General Hospital (MGH) — Montreal, Quebec, Canada
• Montreal Hear Institute — Montreal, Canada

Full record on ClinicalTrials.gov

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