Cryoablation for Monomorphic Ventricular Tachycardia

This study is testing a new device called the Adagio VT Cryoablation System to treat sustained monomorphic ventricular tachycardia (SMVT), a type of fast and irregular heartbeat. The Adagio system uses cryoablation (a procedure that uses extreme cold to destroy abnormal heart tissue) to stop these irregular heartbeats. Researchers want to see how safe and effective this device is for people with SMVT caused by heart disease. To join, you must be at least 18 years old, have SMVT that requires catheter ablation, and already have an implanted cardioverter defibrillator (ICD). The study will look at safety within 7 days of the procedure and how well the treatment works at 6 months.

Study design: This is a single-arm study, meaning all participants will receive the Adagio VT Cryoablation System. It is an open-label study, so both you and your doctors will know you are receiving the study treatment. The study plans to enroll 206 participants.
What's involved: You will undergo a cryoablation procedure using the investigational device. You must also have an Implantable Cardioverter Defibrillator (ICD) before the procedure.
Compensation: Not stated in the trial record.
Follow-up: Your safety will be monitored for 7 days after the procedure, and the effectiveness of the treatment will be assessed at 6 months after the procedure.

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

Active, Not Recruiting

NAAges 18+InterventionalTreatment

Adagio Medical

~206 participants

Updated 2026-08-07 on ClinicalTrials.gov

What's tested:cryoablation procedure

At a glance

Recruiting sites

0 of 15 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Primary Safety Endpoint for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.

Measured over 7 days following the ablation procedure

+2 more outcomes measured

Conditions

Sustained VT

NCT05675865

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Banner University Medical Center Phoenix
Phoenix, Arizonano site contact published
Brigham and Women's Hospital
Boston, Massachusettsno site contact published
Hospital of University of Pennsylvania
Philadelphia, Pennsylvaniano site contact published
Icahn School of Medicine at Mount Sinai
New York, New Yorkno site contact published
Johns Hopkins University
Baltimore, Marylandno site contact published
McGill University
Montreal, Quebec, Canadano site contact published
Medical Center of South Carolina (MUSC)
Charleston, South Carolinano site contact published
Montreal Heart Institute
Montreal, Quebec, Canadano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Want this trial checked against your situation?

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

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

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 for EFS and Pivotal phases is freedom from definite or probable device or procedure related Major Adverse Events (MAEs) that occur within 7 days following the cryoablation procedure.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 Procedural Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with non-inducible VT or no further ablation targets meeting the criteria for ablation at the end of the cryoablation procedure.During Procedure
Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.
Primary Efficacy Endpoint for Pivotal Phase6 months after the procedure
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.

Trialytics