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The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HeartLight X3 | Experimental | Pulmonary vein isolation using HeartLight X3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HeartLight X3 | Device | Pulmonary vein isolation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ablation time | Ablation time | Acute - at the end of the index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Procedure time | Acute - at the end of the index procedure |
| PV Isolation | Percent of isolated pulmonary veins | Acute - at the end of the index procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Burke T. Barrett | CardioFocus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemocnice Na Homolce | Prague | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33570423 | Derived | Schmidt B, Petru J, Chun KRJ, Sediva L, Bordignon S, Chen S, Neuzil P. Pivotal Study of a Novel Motor-Driven Endoscopic Ablation System. Circ Arrhythm Electrophysiol. 2021 Mar;14(3):e009544. doi: 10.1161/CIRCEP.120.009544. Epub 2021 Feb 11. |
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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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| PAE Rate | Primary Adverse Event rate | 30 Days |
| AF Free Rate | 6- and 12-month chronic results | 6 and 12 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |