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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
130
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom
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
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