A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
不适用
已完成
NCT05971693
| 适应症 | Atrial Fibrillation |
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| 分期 | 不适用 |
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| 申办方 | Biosense Webster, Inc. |
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| 状态 | 已完成 |
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| 受试者人数 | 188 人 |
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| 干预(药物) | OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
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| 开始日期 | 2023年9月12日 |
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| 完成日期 | 2024年12月10日 |
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| 结果公布日 | 2026年3月25日 |
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摘要
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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本页整理自 ClinicalTrials.gov 的公开数据,不构成医疗建议,也不构成投资建议。请务必咨询专业医师。