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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Диагностический тест Transthoracic Echocardiography
  After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.

Первичные конечные точки

• Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation [Срок оценки: 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 [Срок оценки: 12 months]

Вторичные конечные точки (7)

• Surgical success rate [Срок оценки: 24 months]
• Success rate of LAA closure at 3 months after operation [Срок оценки: 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 [Срок оценки: 24 months]
• (4)Perioperative (7 days after operation or before discharge) surgery-related complications [Срок оценки: 7 days]
• Procedure-related complications during follow-up [Срок оценки: 24 months]
• Occluder defects during operation and in the 3rd month after operation [Срок оценки: 3 months]
• Incidence rate of severe adverse events within 24 months after operation [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

Китай · 5 центров

• Qilu Hospital of Shandong University — Цзинань
• Shanghai Songjiang District Central Hospital — Шанхай
• Sichuan Mianyang 404 Hospital — Mianyang
• The first Affiliated Hospital of WMU — Wenzhou
• The Second Affiliated Hospital and Yuying Children's Hospital of WMU — Wenzhou

Идентификаторы

NCT: NCT04559243 · LAAC-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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