VT Cryoablation System Post-Market Clinical Follow-up (PMCF) Study

NCT06384599 | Not Yet Recruiting DMC

• 1 other identifier: CS-190
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

The PMCF is a prospective, single-arm, multi-center, controlled study of up to 130 patients designed to collect safety and performance data regarding the use of the Adagio VT Cryoablation System in the treatment of recurrent ventricular tachycardia.

Conditions

Ventricular Tachycardia

Keywords

Monomorphic Ventricular Tachycardia; VT; Cryoablation

Outcome Measures

Primary Outcomes (2)

• Primary Performance Endpoint

  Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period

  6 months

• Primary Safety Endpoint

  Freedom from device / procedure related major adverse events (MAE) during and after the ablation procedure through 30 days follow up. MAEs include: * Death * MI * Cardiac perforation / pericardial tamponade * Cerebral infarct or systemic embolism * Major bleeding requiring transfusion * Heart valve damage resulting in moderate to severe regurgitation * Access site complications requiring surgical intervention * Pericarditis * Heart block requiring a pacemaker implant * Other serious adverse device effects (SADEs).

  30 Days

Secondary Outcomes (2)

• Secondary Performance Endpoint

  During the procedure

• Secondary Safety Endpoint

  6 months

Study Arms (1)

VT Cryoablation Arm

EXPERIMENTAL

all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month

Device: VT Cryoablation System

Interventions

VT Cryoablation System DEVICE

All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)

VT Cryoablation Arm

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 the ages of ≥ 18 years
• IC 2 Planned ablation procedure according to the indication for use of the Adagio VT Cryoablation System
• IC 3 Subject willing to comply with study requirements and give informed consent
• IC4 Subject has or will be receiving an ICD prior to hospital discharge

You may not qualify if:

• EC 1 In the opinion of the investigator, any known contraindication to a ventricular tachycardia procedure with the Adagio VT Cyroablation System as indicated in the device Instructions For Use (IFU)
• EC 2 Subject is enrolled in a study that has not been approved for concurrent enrollment by the sponsor
• EC 3 Any other condition that, in the judgement 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, terminal illness with a life expectancy of less than six months, extensive travel away from the research center)

Sponsors & Collaborators

• Adagio Medical: lead

Study Sites (1)

Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

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

CONTACT

(949) 348-1188; njubran@adagiomedical.com

Doug Kurschinski

CONTACT

(949) 348-1188; 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: April 18, 2024
• First Posted: April 25, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 9, 2026

Record last verified: 2025-09

Locations

GB (1)