A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
단계 해당 없음
완료
NCT05971693
| 대상 질환 | Atrial Fibrillation |
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| 임상 단계 | 단계 해당 없음 |
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| 스폰서 | Biosense Webster, Inc. |
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| 상태 | 완료 |
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| 참여자 수 | 188 명 |
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| 중재(약물) | OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
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| 시작일 | 2023년 9월 12일 |
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| 완료일 | 2024년 12월 10일 |
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| 결과 공개일 | 2026년 3월 25일 |
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요약
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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