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

April 6, 2026 updated by: Adagio Medical

Adagio Medical 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Essex Cardiothoracic Centre
        • Contact:
          • Neil Srinivasan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VT Cryoablation Arm
all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month
Device: VT Cryoablation System
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months
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).
30 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the procedure
Secondary Safety Endpoint
Time Frame: 6 months
Freedom from serious adverse events at 6M following discharge.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adagio Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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