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Recruiting Observational

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

NCT04559243 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2020-11-12
Last updated
2022-12-19

Condition(s) studied

Non-valvular Atrial FibrillationEmbolic Stroke

Investigational drug(s) / intervention(s)

Transthoracic Echocardiography

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

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 18 years, male or female; * Patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (ICF), and are willing to complete the follow-up as required by the protocol; * Indications for left atrial appendage closure; * Patients with non-valvular AF complicated with previous AF related embolic event and meeting one of the following conditions; 1. HAS-BLED bleeding risk score ≥ 3 points; 2. Not suitable for long-term oral anticoagulant therapy; 3. Poor compliance with oral anticoagulants; 4. CHA2DS2-VASc score ≧ 2 points; Exclusion Criteria: * Valvular AF (after moderate to severe mitral stenosis or mechanical valve replacement) * Initial AF, reversible AF with clear cause * Presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus * ST elevation myocardial infarction, ≤ 3 months * Grade-IV of Cardiac Function (NYHA) * Allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants * Pregnant or with plan of pregnancy during the study * Participation in another drug or medical device clinical trial or study that has not been completed * Experience new stroke or TI within 30 days or major bleeding events within 14 days * Contraindication to LAA closure or deemed unsuitable for study participation by the investigator * Had a definite thromboembolic event

Primary outcome measure(s)

  • Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation — 12 months
    Ischemic stroke, systemic embolism, and cardiac death events
  • Incidence of major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells) at 12 months after operation — 12 months
    Bleeding events

Trial sites (5)

FacilityCityRegionStatus
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shanghai Songjiang District Central Hospital Shanghai Shanghai Municipality Recruiting
Sichuan Mianyang 404 Hospital Mianyang Sichuan Recruiting
The first Affiliated Hospital of WMU Wenzhou Zhejiang Recruiting
The Second Affiliated Hospital and Yuying Children's Hospital of WMU Wenzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04559243 on ClinicalTrials.gov ↗ ← All trials in China