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The trial stopped prematurely because of enrollment challenges.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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The electrical isolation of the pulmonary veins (PVI) is the cornerstone of current ablation techniques for the treatment of atrial fibrillation (AF) because the PV is the most common trigger of AF. Wide bi-antral circumferential ablation (WACA) is more effective than segmental PV isolation in achieving freedom from total atrial tachyarrhythmia recurrence at long-term follow-up. Therefore, it is widely accepted as initial ablation strategy. However, the WACA technique requires a much larger number of ablation and higher energy to achieve complete isolation because of thick atrial myocardial sleeves with multiple muscle layers present in most of the PV antrum, which is less likely to achieve homogenous transmural lesions in the entire circumference with the currently available ablation technologies. Meanwhile, muscular discontinuities and abrupt changes of the fiber orientation in human PV-Left atrium (LA) junction are previously reported, and electrical PV isolation can usually be achieved without complete circumferential ablation. However, the current electroanatomical mapping (EAM) system has a limitation to understand the complex relationship of PV-LA junction mainly due to relatively low resolution.
The Rhythmia mapping system (BostonScientific, Inc, Cambridge, MA) is a new system provides ultra-high-resolution EAM using a small basket array of 64 electrodes (IntellaMap Orion, Boston Scientific). Owing to better resolution, this new system capable of rapidly and accurately identify critical isthmuses and low-voltage regions of interest and also allows automatic acquisition and accurate annotation of the electrograms, without the need for manual correction.
In this context, we hypothesized that rapid and precise identification of activation pattern of PV-LA junction by Rhythmia system could allow complete, durable electrical isolation of PVs without circumferential antral ablation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PVI using Ultra-High-Resolution Mapping | The paroxysmal atrial fibrillation patients who received pulmonary vein antral catheter ablation for electrical isolation of pulmonary veins using ultra-high-resolution mapping system (Rhythmia High Density mapping system). |
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| Measure | Description | Time Frame |
|---|---|---|
| Atrial arrhythmia recurrence | recurrence of atrial tachyarrhythmia after the index procedure | one year |
| Measure | Description | Time Frame |
|---|---|---|
| acute pulmonary vein isolation rate | Percentage of patients who are able to obtain pulmonary vein isolation during the procedure | During procedure |
| acute pulmonary vein reconnection rate | Percentage of patients who achieve pulmonary vein isolation during the procedure but have PV reconnection within the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Paroxysmal atrial fibrillation patients who received pulmonary vein isolation using Rhythmia HDx mapping system in Keimyung University Dongsan Medical Center.
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| Name | Affiliation | Role |
|---|---|---|
| Seongwook Han, MD, PhD | Keimyung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keimyung University Dongsan Medical Center | Daegu | 41931 | South Korea |
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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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| During procedure |
| percentage of ablation area in the antrum | Area of pulmonary vein antrum ablated to obtain pulmonary vein isolation | During procedure |
| Procedural outcome | procedure time in minute | During procedure |
| Procedural outcome | fluoroscopic time in minute | During procedure |
| Procedural outcome | total ablation time in minute | During procedure |
| Procedural outcome | procedural complications - number of patients who experienced complications | During procedure |
| D013568 |
| Pathological Conditions, Signs and Symptoms |