Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transthoracic Echocardiography.
- Who it may be relevant to
- Registry conditions: Non-valvular Atrial Fibrillation, Embolic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
Study Population Patients with non-valvular atrial fibrillation and previous AF-related embolic events Purpose To assess the feasibility and safety of percutaneous LAA closure as secondary prevention for patients with non-valvular atrial fibrillation (NVAF) and previous atrial fibrillation (AF) related embolic events (including ischemic stroke, transient ischemic attack (TIA), and systemic embolism).
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.
Primary outcome measures
- Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation [Time frame: 12 months]
- 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 [Time frame: 12 months]
Secondary outcome measures (7)
- Surgical success rate [Time frame: 24 months]
- Success rate of LAA closure at 3 months after operation [Time frame: 3 months]
- The composite endpoint of new ischemic stroke, systemic embolism and cardiac death at 7 months after operation or before discharge and at 1, 3, 6 and 24 months after operation [Time frame: 24 months]
- (4)Perioperative (7 days after operation or before discharge) surgery-related complications [Time frame: 7 days]
- Procedure-related complications during follow-up [Time frame: 24 months]
- Occluder defects during operation and in the 3rd month after operation [Time frame: 3 months]
- Incidence rate of severe adverse events within 24 months after operation [Time frame: 24 months]
Eligibility 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;
- HAS-BLED bleeding risk score ≥ 3 points;
- Not suitable for long-term oral anticoagulant therapy;
- Poor compliance with oral anticoagulants;
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
China · 5 centers
- Qilu Hospital of Shandong University — Jinan
- Shanghai Songjiang District Central Hospital — Shanghai
- Sichuan Mianyang 404 Hospital — Mianyang
- The first Affiliated Hospital of WMU — Wenzhou
- The Second Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou
Identifiers
NCT: NCT04559243 · LAAC-01