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Not yet recruiting NCT06384599

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

No phase Interventional Ventricular Tachycardia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VT Cryoablation System.
Who it may be relevant to
Registry conditions: Ventricular Tachycardia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

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

Primary outcome measures

  • Primary Performance Endpoint [Time frame: 6 months]
  • Primary Safety Endpoint [Time frame: 30 Days]
Secondary outcome measures (2)
  • Secondary Performance Endpoint [Time frame: During the procedure]
  • Secondary Safety Endpoint [Time frame: 6 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United Kingdom · 1 center
  • Essex Cardiothoracic Centre — Basildon

Identifiers

NCT: NCT06384599 · CS-190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗