Amplatzer Amulet China Post Market Study (PMS)

不适用 提前终止 NCT06189365

摘要

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

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

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

在 BENITIONS 中查看 查看 ClinicalTrials.gov 原文

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