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A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVO | Device | VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure the effectiveness of VIVO within different types of VA procedures | The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia. Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure to include the number of VT vs PVC, whether VIVO improved procedural planning and acute procedural success measured as termination or reduction in arrhythmia. | 1 day |
| Measure the safety by observing adverse events related to the device and procedure | Primary safety objective is to assess any adverse events related to the device and procedure. Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Secondary effectiveness objective is to evaluate the success of the ablation procedure (if performed) at follow- up visits (3, 6 and 12 months). Secondary effectiveness endpoint: Summarize the success of the ablation procedure at each follow up visit. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
• Patients that are unable to receive contrast cardiac imaging (MR or CT)
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Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Andre Ng, MD | Glenfield University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mater Private Hospital | Dublin | Ireland | ||||
| Mazzoni Hospital |
NO IPD is to be shared with other researchers.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 16, 2025 | |
| Reset | Aug 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 16, 2025 | Aug 4, 2025 |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Ascoli Piceno |
| Italy |
| University Medical Center Groningen | Groningen | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| La Luz Hospital | Lisbon | Portugal |
| Glenfield University Hospital | Leicester | United Kingdom |
| Royal Brompton Hospital | London | United Kingdom |
| John Radcliffe University Hospital | Oxford | United Kingdom |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |