Cryoablation for Monomorphic Ventricular Tachycardia (VTS)

This study is testing a new device called the Adagio Medical vCLAS Ventricular Ablation System (including VTS Catheter and Console) for treating Sustained Monomorphic Ventricular Tachycardia (SMVT), a type of fast, abnormal heart rhythm. The goal is to see how safe and effective this device is. You might be able to join if you are 18 or older, have SMVT that needs catheter ablation due to heart disease, and have an Implantable Cardioverter Defibrillator (ICD). Success in this study means being free from serious device or procedure-related problems within 7 days, and being free from recurrent SMVT for 6 months after the procedure without needing new or increased medication. The study is currently collecting data, but its overall status is unclear.

Study design: This is a single-arm study, meaning all participants receive the same treatment, and it aims to enroll 100 people. It is an open-label study, so both you and the study team will know what treatment you are receiving.
What's involved: You would undergo an ablation procedure using the investigational device. The study will measure outcomes at the end of the procedure, 7 days after, and 6 months after.
Compensation: Not stated in the trial record.
Follow-up: You would be followed for at least 6 months after the ablation procedure to check for recurrent heart rhythms.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Cryoablation for Monomorphic Ventricular Tachycardia (VTS)

Recruiting

NAAges 18+InterventionalTreatment

Adagio Medical

~100 participants

Updated 2026-08-12 on ClinicalTrials.gov

What's tested:Ultra Low Temperature Ablation (ULTA)

At a glance

Recruiting sites

10 of 10 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.

Measured over 7 days following the ablation procedure

+2 more outcomes measured

Conditions

Ventricular Tachycardia, Sustained

Ventricular Tachycardia, Monomorphic

Where it's being run

10 sites across 10 states

Arizona1

California1

Massachusetts1

New York1

Pennsylvania1

South Carolina1

Tennessee1

Virginia1

Who to contact

Nabil Jubran, MS

[email protected]

949 329 2494 · ext. 207

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

Exclusion

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:

EC 4 NICM patients only, if any of the following apply:

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:

EC 9 Acute illness or active systemic infection

EC 10 Any previous history of cryoglobulinemia

EC 11 History of blood clotting or bleeding disease

EC 12 Peripheral vascular disease that precludes LV access

EC 13 Contraindication to heparin

EC 14 Allergy to radiographic contrast dye that cannot be medically managed prior to the ablation procedure

EC 15 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 16 Pregnant, or anticipated pregnancy during study follow-up

EC 17 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study

EC 18 Any other condition (e.g., ARVC with extensive free wall scarring) 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)

What this trial measures

Primary Safety Endpoint - Freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure.7 days following the ablation procedure
Primary Safety Endpoint is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the ablation procedure. Events will be adjudicated by an independent Clinical Events Committee (CEC). MAEs include any of the following: • Death • Acute myocardial infarction • Cardiac perforation/pericardial tamponade • Cerebral infarct or systemic embolism • Major bleeding requiring transfusion • Acute Mitral, Tricuspid or Aortic valve damage resulting in moderate or severe regurgitation • Access site complications requiring medical or surgical intervention • Pericarditis • Heart block requiring a permanent pacemaker • Other serious adverse device effects (SADEs), including TIAs, adjudicated by an independent Clinical Events Committee (CEC) to be probably or definitely related to the Adagio System.
Primary Efficacy Endpoint - Freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure6 months after the procedure
Primary Efficacy Endpoint is defined as freedom from recurrent sustained MMVT in the absence of a new AAD or increase in dose of a pre-ablation AAD for VT management at 6 months following the ablation procedure, where sustained MMVT is defined as continuous MMVT for \> 30 seconds (programmed monitoring zone only), or MMVT requiring appropriate ICD intervention regardless of duration. All ICD interrogation reports will be adjudicated by an independent VT Event Committee (VTEC) to support the primary efficacy endpoint.
Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedureat the end of the ablation procedure
Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure

Trialytics