Closure of the left atrial appendage to prevent embolic events in atrial fibrillation patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the safety and effectiveness of the LAmbre™ Left Atrial Appendage Occluder System in patients with non-valvular atrial fibrillation who have experienced previous AF-related embolic events. A total of 579 patients will be enrolled across approximately 20 study sites nationwide. The study will collect baseline data, operational processes, and follow-up information at various intervals up to 24 months post-operation. The aim is to assess the feasibility of using percutaneous left atrial appendage closure as a secondary prevention method for these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting
• Shanghai Songjiang District Central Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Sichuan Mianyang 404 Hospital
  Mianyang, Sichuan, China Recruiting
• The first Affiliated Hospital of WMU
  Wenzhou, Zhejiang, China Recruiting
• The Second Affiliated Hospital and Yuying Children's Hospital of WMU
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Chenyang Jiang, Doctor — Sir Run Run Shaw Hospital
• Study coordinator: Chenyang Jiang, Doctor
• Email: panshangming@lifetechmed.com
• Phone: 8613857190051

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Appendage-Closing LAA Procedure Without Implants

  This procedure tests whether the Append System can safely close the left atrial appendage in adults with non-valvular atrial fibrillation.

  Recruiting Append Medical Ltd. · Prague · NCT07816029

• Append System for closing the left atrial appendage

  This study will test whether the Append System can safely close the left atrial appendage to lower stroke risk in adults with non-valvular atrial fibrillation.

  Recruiting at 3 sites Append Medical Ltd. · Jonesboro, Arkansas and 2 other locations · NCT07278869

• Assessing stroke risk in patients with newly diagnosed atrial fibrillation

  This study is testing how to identify stroke risk in people who have just been diagnosed with atrial fibrillation to see who might need blood-thinning medication to prevent strokes.

  Recruiting University of Southern Denmark · Esbjerg, Region Syddanmark · NCT06949319

• Effects of anticoagulant interruption and left atrial occlusion in patients with bleeding from radiation cystitis and atrial fibrillation

  This study looks at patients who have bleeding from radiation cystitis while on blood thinners for atrial fibrillation to see how these factors affect their treatment and outcomes.

  Recruiting University Hospital, Clermont-Ferrand · Clermont-Ferrand · NCT04701749

• PFO closure versus blood thinners to prevent repeat stroke in older adults

  This study will test whether closing a patent foramen ovale or taking direct oral anticoagulants better prevents repeat strokes in adults over 60 with PFO-related embolic stroke.

  Recruiting at 3 sites Taichung Veterans General Hospital · Taichung and 2 other locations · NCT07479147

• AI analysis of ECGs to predict atrial fibrillation risk in ESUS patients with an implantable cardiac monitor.

  This project tests whether an AI tool called SmartECG-AF can use a routine 12-lead ECG to predict which ESUS patients with an implantable cardiac monitor will develop atrial fibrillation.

  Recruiting at 5 sites Inha University Hospital · Ansan and 4 other locations · NCT07347691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.