Amplatzer Amulet China Post Market Study (PMS)
該当なし
早期終了
NCT06189365
| 対象疾患 | Non-Valvular Atrial Fibrillation |
|---|
| 相 | 該当なし |
|---|
| スポンサー | Abbott Medical Devices |
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| ステータス | 早期終了 |
|---|
| 参加者数 | 50 名 |
|---|
| 介入(薬剤) | Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder |
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| 開始日 | 2024年1月30日 |
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| 完了日 | 2025年12月5日 |
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| 結果公開日 | 2026年7月2日 |
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概要
The purpose of this study is to prospectively evaluate the safety and effectiveness of the Amplatzer Amulet LAA occluder in a Chinese patient population indicated for use of this device.
Primary Short-Term Safety Endpoint: Occurrence of Major Adverse Events
7 days · Participants
| Amulet Left Atrial Appendage Occluder | 0 Participants |
|---|
Primary Long-Term Safety Endpoint: Occurrence of Device Embolization, Device Erosion, Significant Device Interference With Surrounding Structure, Device Thrombus, Device Fracture, Device Related Infections, Device Breakage, or Device Related Allergy
2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) · Participants
| Amulet Left Atrial Appendage Occluder | 5 Participants |
|---|
Primary Effectiveness Endpoint: Composite of Ischemic Stroke or Systemic Embolism
2 years (The study was terminated at 1 year and 11 months after study start, and the endpoint was evaluated based on all available data.) · Participants
| Amulet Left Atrial Appendage Occluder | 0 Participants |
|---|
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