Cryoablation for Monomorphic Ventricular Tachycardia

NCT05675865 | Recruiting DMC FDA Device

• 1 other identifier: CS-300
• Study Type: interventional
• Target: 206
• Locations: 2 countries
• Sites: 15

Brief Summary

The objective of this clinical study is to evaluate the safety and effectiveness of the Adagio VT Cryoablation System in the ablation treatment of Sustained Monomorphic Ventricular Tachycardia (SMVT)

Conditions

Sustained VT

Keywords

cryoablation; monomorphic VT; sustained monomorphic VT

Outcome Measures

Primary Outcomes (3)

• 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.

  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 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.

  Documentation of non-inducibility of any VT targeted for ablation at the end of procedure.

  During Procedure

• Primary Efficacy Endpoint for Pivotal Phase

  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

Secondary Outcomes (7)

• Secondary Safety Endpoint - Analysis of the proportion of subjects with freedom from definite or probable device or procedure related MAEs that occur within 30 days (EFS) or SAEs within 12 months (pivotal) following the cryoablation procedure.

  1 month post cryoablation procedure

• Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from inducible MMVT <30s

  6-month post cryoablation procedure

• Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds

  6-month post cryoablation procedure

• Secondary Efficacy Endpoint for EFS and Pivotal - Analysis of the proportion of subjects with freedom from VT > 30 seconds without AAD

  6-month post cryoablation procedure

• Health Outcomes for EFS and Pivotal phases are defined as all-cause mortality at 12 months

  12-months post cryoablation procedure

Study Arms (1)

VT Cryoablation

EXPERIMENTAL

all enrolled patients will have a ablation procedure using the Adagio VT Cryoablation System for SMVT

Device: cryoablation procedure

Interventions

cryoablation procedure DEVICE

ablation procedure for VT using the investigational device

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 (15)

Banner University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Weill Cornell Medical Center

New York, New York, 10065, United States

RECRUITING

Northwell Health- Staten Island University Hospital

Staten Island, New York, 10305, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical Center of South Carolina (MUSC)

Charleston, South Carolina, 29403, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Texas Cardiac Arrhythmia Research Institute (TCARF)

Austin, Texas, 78705, United States

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

McGill University

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• Weiss JP, Reddy VY, Tandri H, Richardson TD, Gerstenfeld EP, Stevenson WG, Jubran N, Grigorov I, Tung R. Ultra-Low Cryoablation for Scar-Related VT Ablation: Results From the US Early Feasibility Study. Circ Arrhythm Electrophysiol. 2026 Feb 2:e014095. doi: 10.1161/CIRCEP.125.014095. Online ahead of print.

  PMID: 41623095 DERIVED

Central Study Contacts

Nabil Jubran

CONTACT

949 348 1188; 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: December 14, 2022
• First Posted: January 9, 2023
• Study Start: September 11, 2023
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (13)