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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT Cryoablation Arm | Experimental | all subjects will receive a cryoablation procedure with the VT System and be followed up for 6-month |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT Cryoablation System | Device | All subjects will receive a cryoablation procedure using the VT Cryoablation System (catheter, stylets, and console) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance Endpoint | Freedom from ventricular tachycardia or appropriate ICD intervention until the end of the 6 month follow up period | 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:
| 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 Safety Endpoint |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nabil Jubran | Contact | (949) 348-1188 | njubran@adagiomedical.com | |
| Doug Kurschinski | Contact | (949) 348-1188 | dkurschinski@adagiomedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Essex Cardiothoracic Centre | Basildon | Essex | SS16 5NL | United Kingdom |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Freedom from serious adverse events at 6M following discharge.
| 6 months |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |