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Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events

NCT04559243 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 579

Last updated 2022-12-19

No results posted yet for this study

Summary

This clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous LAA appendage closure by using LAmbre™ Left Atrial Appendage Occluder System. 579 patients with valvular AF complicated with previous AF-related embolic events (including ischemic stroke, TIA and systemic embolism) were enrolled at about 20 study sites nationwide. The baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.

Conditions

  • Non-valvular Atrial Fibrillation
  • Embolic Stroke

Interventions

DIAGNOSTIC_TEST

Transthoracic Echocardiography

After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chenyang Jiang, Doctor · Sir Run Run Shaw Hospital

  • Jinhua Zhang, Doctor · Sir Run Run Shaw Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-12
Primary Completion
2025-11-30
Completion
2027-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04559243 on ClinicalTrials.gov