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NCT Number: NCT04559243

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

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.

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Key information

Conditions

Non-valvular Atrial Fibrillation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolic Stroke Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University, Jinan, Shandong, China

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transthoracic echocardiography

Diagnostic Test

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

Other names: Transesophageal Echocardiography

Primary outcomes

  1. 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

  2. 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

  1. Surgical success rate

    Time frame: 24 months

    Surgical success

  2. Success rate of LAA closure at 3 months after operation

    Time frame: 3 months

    Successful LAA closure was defined as a residual shunt ≤ 3 mm by TEE or ICE after implantation of the LAA occluder.

  3. 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

    Ischemic stroke, systemic embolism, and cardiac death events

  4. (4)Perioperative (7 days after operation or before discharge) surgery-related complications

    Time frame: 7 days

    7 days after operation or pre-discharge procedure-related complications include but are not limited to stroke (ischemic and hemorrhagic stroke), systemic embolism, allergic reaction, gas embolism, pericardial effusion/cardiac tamponade requiring intervention, occluder detachment, occluder thrombosis (DRT), minor bleeding events (including but not limited to puncture site hematoma, non-major bleeding events), infection, arrhythmia, damage to blood vessels or organs on the implantation path and adjacent organs

  5. Procedure-related complications during follow-up

    Time frame: 24 months

    Follow-up at 1, 3, 6, 12 and 24 months after operation for procedure-related complications, including all-cause death, stroke (ischemic and hemorrhagic stroke), cardiac perforation, pericardial effusion/cardiac tamponade requiring intervention, major bleeding events (intracranial or gastrointestinal, or any bleeding requiring transfusion of ≥ 2 units of red blood cells), occluder thrombosis (DRT), infection, systemic embolism, allergic reaction, arrhythmia, and other serious cardiovascular events requiring intervention or surgical treatment

  6. Occluder defects during operation and in the 3rd month after operation

    Time frame: 3 months

    Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc

  7. Incidence rate of severe adverse events within 24 months after operation

    Time frame: 24 months

    including but not limited to all-cause death, events requiring hospitalization or prolongation of hospitalization, severe endocarditis requiring surgery, pericarditis, cardiac perforation, valvular injury, vascular or gas embolism events, occluder detachment/displacement, occluder fracture, occluder thrombosis (DRT), stroke events

Study contacts

Contact information is provided by the study sponsor or research team.

Chenyang Jiang, Doctor

CONTACT

[email protected]

8613857190051

Sponsors and collaborators

Lead sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2025
Study completion
2027
First posted
Sep 22, 2020
Registry last updated
Dec 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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