BENITIONSClinical Trial Intelligence

Amplatzer Amulet China Post Market Study (PMS)

단계 해당 없음 조기 종료 NCT06189365

대상 질환Non-Valvular Atrial Fibrillation
임상 단계단계 해당 없음
스폰서Abbott Medical Devices
상태조기 종료
참여자 수50 명
중재(약물)Left Atrial Appendage (LAA) closure procedure with Amplatzer Amulet LAA occluder
시작일2024년 1월 30일
완료일2025년 12월 5일
결과 공개일2026년 7월 2일

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 Occluder0 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 Occluder5 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 Occluder0 Participants

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