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
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non-valvular Atrial Fibrillation
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 579
- Locations
- 5
- Primary Endpoint
- Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
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).
Investigators
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
Outcomes
Primary Outcomes
Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
Time Frame: 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
Time Frame: 12 months
Bleeding events
Secondary Outcomes
- Surgical success rate(24 months)
- Incidence rate of severe adverse events within 24 months after operation(24 months)
- Success rate of LAA closure at 3 months after operation(3 months)
- (4)Perioperative (7 days after operation or before discharge) surgery-related complications(7 days)
- Occluder defects during operation and in the 3rd month after operation(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(24 months)
- Procedure-related complications during follow-up(24 months)