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NCT Number: NCT06384599

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location contact

Neil Srinivasan

CONTACT

About this study

This VT Post-Market Clinical Follow-up (PMCF) study continues collecting additional information about the Adagio Medical VT Cryoablation System in real world clinical settings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

VT Cryoablation System

Device

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

Primary outcomes

  1. Primary Performance Endpoint

    Time frame: 6 months

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

  2. Primary Safety Endpoint

    Time frame: 30 Days

    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).

Secondary outcomes

  1. Secondary Performance Endpoint

    Time frame: During the procedure

    Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.

  2. Secondary Safety Endpoint

    Time frame: 6 months

    Freedom from serious adverse events at 6M following discharge.

Study contacts

Contact information is provided by the study sponsor or research team.

Doug Kurschinski

CONTACT

[email protected]

(949) 348-1188

Nabil Jubran

CONTACT

[email protected]

(949) 348-1188

Sponsors and collaborators

Lead sponsor

Adagio Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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