BENITIONSClinical Trial Intelligence

Amplatzer Amulet China Post Market Study (PMS)

該当なし 早期終了 NCT06189365

対象疾患Non-Valvular Atrial Fibrillation
該当なし
スポンサーAbbott Medical Devices
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
開始日2024年1月30日
完了日2025年12月5日
結果公開日2026年7月2日

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 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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