Cryoablation for Monomorphic Ventricular Tachycardia (VTS)

NCT07650032 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CS-300 Rev.H
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 10

Brief Summary

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)

Conditions

Ventricular Tachycardia, Sustained; Ventricular Tachycardia, Monomorphic

Keywords

cryoablation; monomorphic VT; sustained monomorphic VT; Ultra Low Temperature Ablation; ULTA

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  7 days following the ablation procedure

• 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 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.

  6 months after the procedure

• Primary Procedural Endpoint - Percentage of non-inducibility VT targeted for ablation post-procedure

  Primary Procedural Endpoint is defined as non-inducibility of any VT targeted for ablation at the end of the procedure

  at the end of the ablation procedure

Secondary Outcomes (2)

• Secondary Safety Endpoint - Freedom from definite or probable device or procedure related Serious Adverse Events (SAEs) within 12 months following the ablation procedure

  12-months post ablation procedure

• Secondary Efficacy Endpoint - Freedom from VT greater than 30 seconds or appropriate ICD intervention at 12 months

  12-months post ablation procedure

Study Arms (1)

VT Cryoablation

EXPERIMENTAL

all enrolled patients will have a ablation procedure using the vCLAS Ventricular Ablation System (VTS Catheter and Console) for SMVT

Device: Ultra Low Temperature Ablation (ULTA)

Interventions

Ultra Low Temperature Ablation (ULTA) DEVICE

ablation procedure using the investigational device (vCLAS Ventricular Ablation System including VTS Catheter and Console)

VT Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (10)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

MemorialCare Long Beach Medical Center

Long Beach, California, 90806, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Northwell Health- Staten Island University Hospital

Staten Island, New York, 10305, United States

Location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Medical Center of South Carolina (MUSC)

Charleston, South Carolina, 29403, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

McGill University Health Centre (MUHC), Montreal General Hospital (MGH)

Montreal, Quebec, H3G 1A4, Canada

Location

Montreal Hear Institute

Montreal, Canada

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nabil Jubran, MS

CONTACT

949 329 2494; njubran@adagiomedical.com

Doug Kurschinski

CONTACT

dkurschinski@adagiomedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: June 16, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

CA (2); US (8)