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

NCT04559243 | Recruiting

• 1 other identifier: LAAC-01
• Study Type: observational
• Target: 579
• Locations: 1 country
• Sites: 5

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.

Conditions

Non-valvular Atrial Fibrillation; Embolic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Incidence of new ischemic stroke, systemic embolism, and cardiac death 12 months after operation

  Ischemic stroke, systemic embolism, and cardiac death events

  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

  Bleeding events

  12 months

Secondary Outcomes (7)

• Surgical success rate

  24 months

• Success rate of LAA closure at 3 months 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

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

  7 days

• Procedure-related complications during follow-up

  24 months

Interventions

Transthoracic Echocardiography DIAGNOSTIC_TEST

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

Also known as: Transesophageal Echocardiography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with non-valvular atrial fibrillation and previous AF-related embolic events

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (5)

Qilu Hospital of Shandong University

Jinan, Shandong, 250000, China

RECRUITING

Shanghai Songjiang District Central Hospital

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Sichuan Mianyang 404 Hospital

Mianyang, Sichuan, 621000, China

RECRUITING

The first Affiliated Hospital of WMU

Wenzhou, Zhejiang, 325600, China

RECRUITING

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

Wenzhou, Zhejiang, 325600, China

RECRUITING

MeSH Terms

Conditions

Embolic Stroke

Interventions

Echocardiography; Echocardiography, Transesophageal

Condition Hierarchy (Ancestors)

Ischemic Stroke; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Chenyang Jiang, Doctor

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Jinhua Zhang, Doctor

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chenyang Jiang, Doctor

CONTACT

8613857190051; panshangming@lifetechmed.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 22, 2020
• Study Start: November 12, 2020
• Primary Completion: November 1, 2025
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 19, 2022

Record last verified: 2022-11

Locations

CN (5)