Amplatzer Amulet China Post Market Study (PMS)
단계 해당 없음
조기 종료
NCT06189365
| 대상 질환 | Non-Valvular Atrial Fibrillation |
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| 임상 단계 | 단계 해당 없음 |
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| 스폰서 | Abbott Medical Devices |
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| 상태 | 조기 종료 |
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| 참여자 수 | 50 명 |
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| 중재(약물) | Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder |
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| 시작일 | 2024년 1월 30일 |
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| 완료일 | 2025년 12월 5일 |
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| 결과 공개일 | 2026년 7월 2일 |
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요약
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 |
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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 |
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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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