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The objective of the study is to collect data on the usability and integration of the VERAFEYE Imaging and Guidance System in adult patients indicated to undergo a standard of care catheter-based ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
Results from this study may be used to guide development and refinement the VERAFEYE Imaging and Guidance System capabilities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation and Atrial Flutter arm | Experimental | Subjects entitled to undergo a catheter-based ablation treatment for typical atrial flutter and/or atrial fibrillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VERAFEYE Imaging and Guidance System | Device | The VERAFEYE Imaging and Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| ADEs | • Rate of device-related adverse events (ADEs) occurring within 7 days of the index procedure | within 7 days of the index procedure |
| VERAFEYE Performance | • Ability of VERAFEYE Imaging and Guidance System to:
| during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivan Sikiric | Contact | +385958934912 | ivan.sikiric20@gmail.com | |
| Ivan Aranza | Contact | +385917947452 | aranza.ivan@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinicki Bolnicki Centar (KBC) Split | Recruiting | Split | 21000 | Croatia |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |