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

Ventricular Tachycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384599
• Other study ID #: CS-190
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Adagio Medical
• Contact: Nabil Jubran
• Phone: (949) 348-1188
• Email: njubran[@]adagiomedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Essex Cardiothoracic Centre	Basildon	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Adagio Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Performance Endpoint	Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period	6 months
Primary	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	Secondary Performance Endpoint	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	Secondary Safety Endpoint	Freedom from serious adverse events at 6M following discharge.	6 months