A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator
該当なし
完了
NCT05971693
| 対象疾患 | Atrial Fibrillation |
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| 相 | 該当なし |
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| スポンサー | Biosense Webster, Inc. |
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| ステータス | 完了 |
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| 参加者数 | 188 名 |
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| 介入(薬剤) | OMNYPULSE Bi-Directional Catheter with TRUPULSE Generator |
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| 開始日 | 2023年9月12日 |
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| 完了日 | 2024年12月10日 |
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| 結果公開日 | 2026年3月25日 |
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概要
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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