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This is an early feasibility trial designed to demonstrate whether a new ablation device can be used safely and effectively in treating atrial fibrillation.
This study is a prospective, nonrandomized, single-arm, multi-center trial to be conducted at a single study site
This study is intended to evaluate the safety and preliminary effectiveness of the RFMesh BAS for electrophysiological mapping and radiofrequency ablation in the region of the ostium of a targeted pulmonary vein in the treatment of drug refractory paroxysmal atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | RF ablation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF catheter ablation | Device | RF ablation using mesh device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of the HDMA when used to map & ablate patients with AF, by assessing MCs at 7-days & 30 days post-procedure & assessing the occurrence of pulmonary vein stenosis at 3 & 12 months post-procedure. | 12 months | |
| Evaluate the preliminary effectiveness of the HDMA when used to map and ablate patients with paroxysmal AF, by assessing APS & the freedom from recurrence of symptomatic AF at 3, 6 & 12 months post- procedure. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Haines, MD | Royal Oak | Michigan | 48073 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |