A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
Не применимо
Завершено
NCT05971693
| Заболевание | Atrial Fibrillation |
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| Фаза | Не применимо |
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| Спонсор | Biosense Webster, Inc. |
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| Статус | Завершено |
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| Участники | 188 участн. |
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| Вмешательство | OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
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| Дата начала | 12.09.2023 |
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| Дата завершения | 10.12.2024 |
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| Публикация результатов | 25.03.2026 |
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Кратко
The purpose of this study is to demonstrate safety and effectiveness of the ablation system (OMNYPULSE Bi-directional catheter and TRUPULSE generator) when used for isolation of the atrial pulmonary veins (PVs) in treatment of participants with paroxysmal atrial fibrillation (PAF).
Percentage of Participants With Primary Adverse Events (PAEs)
90 days post catheter insertion on Day 0 · Percentage of participants
| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 0 Percentage of participants |
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Percentage of Participants With Acute Effectiveness Success
Immediately post-procedure on Day 0 (post catheter insertion) · Percentage of participants
| Roll-In Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 100 Percentage of participants |
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| Main Safety Analysis Set: OMNYPULSE Bi-Directional Catheter With TRUPULSE Generator | 100 Percentage of participants |
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