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

NCT ID: NCT04559243

Last Updated: 2022-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-12

Study Completion Date

2027-11-30

Brief Summary

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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

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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).

Conditions

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Non-valvular Atrial Fibrillation Embolic Stroke

Keywords

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AF-related embolic events non-valvular atrial fibrillation Left Atrial Appendage Closure

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Interventions

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Transthoracic Echocardiography

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Transesophageal Echocardiography

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chenyang Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Jinhua Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Shaw Hospital

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Shanghai Songjiang District Central Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Sichuan Mianyang 404 Hospital

Mianyang, Sichuan, China

Site Status RECRUITING

The first Affiliated Hospital of WMU

Wenzhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chenyang Jiang, Doctor

Role: CONTACT

Phone: 8613857190051

Email: [email protected]

Facility Contacts

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Zhong Jingquan, Doctor

Role: primary

Zhao Wenbiao, Doctor

Role: primary

Zhang Dayong, Doctor

Role: primary

Huang Weijian, Doctor

Role: primary

Li Yuechun, Doctor

Role: primary

Other Identifiers

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LAAC-01

Identifier Type: -

Identifier Source: org_study_id