An interventional study of VT Cryoablation System in Ventricular Tachycardia, sponsored by Adagio Medical. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Adagio Medical · Not applicable, Interventional, and Treatment
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.
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.
431 studies on the registry are indexed under Tachycardia, Ventricular; 119 are open to participants now.
This study's planned enrollment of 130 is above the median of 64 across 260 interventional studies indexed under Tachycardia, Ventricular.
Browse Tachycardia, Ventricular studies →Adagio Medical is the lead sponsor of 9 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Primary Performance Endpoint
Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period
Time frame: 6 months
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).
Time frame: 30 Days
Secondary Performance Endpoint
Analysis of the proportion of subjects with non-inducible clinical monomorphic VT at the conclusion of the initial cryotherapy ablation procedure.
Time frame: During the procedure
Secondary Safety Endpoint
Freedom from serious adverse events at 6M following discharge.
Time frame: 6 months
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Adagio Medical