Amplatzer Amulet China Post Market Study (PMS)

N/A Terminated NCT06189365

Summary

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

Open in BENITIONS View on ClinicalTrials.gov

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