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The objective of the study is to collect data on the use of the VERAFEYE Anatomical Guidance System in adult patients indicated to undergo a catheter ablation procedure for the treatment of Atrial Flutter (AFL), paroxysmal AF (PAF) or persistent AF (perAF).
The study will collect specific information on management of AFL/AF ablation procedures with the commercial VERAFEYE Anatomical Guidance System including but not limited to acute procedural success , and how the VERAFEYE Anatomical Guidance System is used overall. Results from this study may be used to guide development and refinement the VERAFEYE Anatomical Guidance System.
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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 Anatomic Guidance System | Device | The VERAFEYE Anatomical Guidance System will be used during standard of care, catheter-based treatments for atrial flutter and/or atrial fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute procedural success rates during the index procedure | A procedure will be defined as successful if all the following conditions occur during the case:
| During the procedure |
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Inclusion Criteria:
Exclusion Criteria:
Note: Screening for LA thrombus is required to be performed within 48 hours prior to or during the index procedure. Method of screening per physician discretion. If an atrial thrombus is observed prior to or during the planned index procedure, the index procedure will not begin or will be terminated before accessing the left atrium, and no ablation will be performed. The index procedure for this subject may be rescheduled to be performed within 30 days post ICF signature, provided that the thrombus is no longer present.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alisa Komleva | Contact | 0894352047 | alisa.komleva@lumavision.com | |
| Elke Sommerijns | Contact | +32 479 76 71 56 | Elke.sommerijns@lumavision.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinicki Bolnicki Centar (KBC) | Not yet 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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| Na Homolce Hospital | Recruiting | Prague | 150 30 | Czechia |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |