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

Not Applicable

Not yet recruiting

• Conditions: Ventricular Tachycardia
• Interventions: Device: VT Cryoablation System

• Registration Number: NCT06384599
• Lead Sponsor: Adagio Medical

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-23
• Last Update Submitted: 2024-04-23
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25
• Study Start: 2024-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VT Cryoablation Arm	VT Cryoablation System	all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month

Primary Outcome Measures

Name	Time	Method
Primary Performance Endpoint	6 months	Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Primary Safety Endpoint	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 Outcome Measures

Name	Time	Method
Secondary Safety Endpoint	6 months	Freedom from serious adverse events at 6M following discharge.
Secondary Performance Endpoint	During the procedure	Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.

Trial Locations

Locations (1)

Essex Cardiothoracic Centre; 🇬🇧 Basildon, Essex, United Kingdom