Closure of the left atrial appendage to prevent embolic events in atrial fibrillation patients
A Prospective, Multicenter Clinical Study of Percutaneous Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events in Patients With Atrial Fibrillation
This study is testing if a new device can safely close a part of the heart to help prevent blood clots in people with atrial fibrillation who have already had related health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 579 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lifetech Scientific (Shenzhen) Co., Ltd. Industry-sponsored |
| Locations | 5 sites (Jinan, Shandong and 4 other locations) |
| Trial ID | NCT04559243 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with non-valvular atrial fibrillation and a history of AF-related embolic events.
Not a fit: Patients with valvular atrial fibrillation or those who have reversible atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of future embolic events in patients with non-valvular atrial fibrillation.
How similar studies have performed: Previous studies have shown promise in using left atrial appendage closure for similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jinan, Shandong and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.