Clinical trial NCT04559243: Left Atrial Appendage Closure as Secondary Prevention of Atrial Fibrillation-related Embolic Events
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-valvular Atrial Fibrillation
Embolic Stroke
Keywords: AF-related embolic events
non-valvular atrial fibrillation
Left Atrial Appendage Closure
Lead sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-09-22
Enrollment: 579
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with non-valvular atrial fibrillation and previous AF-related embolic events

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).

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;

  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

Primary outcomes:
measure: Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Surgical success rate
timeFrame: 24 months
measure: Success rate of LAA closure at 3 months after operation
timeFrame: 3 months
measure: 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
timeFrame: 24 months
measure: (4)Perioperative (7 days after operation or before discharge) surgery-related complications
timeFrame: 7 days
measure: Procedure-related complications during follow-up
timeFrame: 24 months
measure: Occluder defects during operation and in the 3rd month after operation
timeFrame: 3 months
measure: Incidence rate of severe adverse events within 24 months after operation
timeFrame: 24 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Songjiang District Central Hospital
state: Shanghai
city: Mianyang
country: China
facility: Sichuan Mianyang 404 Hospital
state: Sichuan
city: Wenzhou
country: China
facility: The first Affiliated Hospital of WMU
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital and Yuying Children's Hospital of WMU
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Chenyang Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital
name: Jinhua Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: