RecruitingNCT04559243

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

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


Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

579 participants

Start Date

Nov 12, 2020

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines whether sealing off a small pouch in the heart called the left atrial appendage (LAA) — using a minimally invasive device — can prevent future strokes in patients with atrial fibrillation (an irregular heartbeat) who have already had a stroke or blood clot and cannot safely take blood thinners long-term. **You may be eligible if...** - You are 18 or older with atrial fibrillation (not caused by a heart valve problem) - You have already had a stroke or blood clot related to atrial fibrillation - You have a high bleeding risk, cannot take blood thinners long-term, have poor compliance with those medications, or have a high stroke risk score **You may NOT be eligible if...** - You have a type of atrial fibrillation caused by heart valve disease - There is a clot already present in your heart - You have had a heart attack in the past 3 months - You have severe heart failure (Class IV) - You are allergic to nitinol, aspirin, clopidogrel, heparin, or other blood thinners - You are pregnant or planning to become pregnant - You have had a stroke or major bleeding in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTTransthoracic Echocardiography

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


Locations(5)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Shanghai Songjiang District Central Hospital

Shanghai, Shanghai Municipality, China

Sichuan Mianyang 404 Hospital

Mianyang, Sichuan, China

The first Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

The Second Affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT04559243


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