Ventricular Tachycardia
Conditions
Keywords
Monomorphic Ventricular Tachycardia, VT, Cryoablation
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.
Interventions
DEVICEVT Cryoablation System
All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console)
Sponsors
Adagio Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Secondary Safety Endpoint | 6 months | Freedom from serious adverse events at 6M following discharge. |
Countries
United Kingdom
Contacts
CONTACTNabil Jubran
CONTACTDoug Kurschinski
Outcome results
None listed