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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Non-valvular Atrial Fibrillation; Embolic Stroke
• Intervention / Treatment: Diagnostic test: Transthoracic Echocardiography

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).

• Study Type: Observational
• Enrollment (Anticipated): 579

Contacts and Locations

• Study Contact: Name: Chenyang Jiang, Doctor; Phone Number: 8613857190051; Email: panshangming@lifetechmed.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Zhong Jingquan, Doctor; Phone Number: 18560086597; Email: 18560086597@163.com
      • Principal Investigator: Zhong Jingquan, Doctor
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Shanghai Songjiang District Central Hospital
      • Contact: Zhao Wenbiao, Doctor; Phone Number: 18918288026
      • Principal Investigator: Zhao Wenbiao, Doctor
  • Sichuan
    • Mianyang, Sichuan, China, 621000
      • Recruiting
      • Sichuan Mianyang 404 Hospital
      • Contact: Zhang Dayong, Doctor; Phone Number: 13890135264; Email: 504082447@qq.com
      • Principal Investigator: Zhang Dayong, Doctor
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325600
      • Recruiting
      • The First Affiliated Hospital Of WMU
      • Contact: Huang Weijian, Doctor; Phone Number: 13806691086; Email: weijianhuang69@126.com
      • Principal Investigator: Huang Weijian, Doctor
    • Wenzhou, Zhejiang, China, 325600
      • Recruiting
      • The Second Affiliated Hospital and Yuying Children's Hospital of WMU
      • Contact: Li Yuechun, Doctor; Phone Number: 13616776960; Email: liyuechun1980@sina.com
      • Principal Investigator: Li Yuechun, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical success rate	Surgical success	24 months
Success rate of LAA closure at 3 months after operation	Successful LAA closure was defined as a residual shunt ≤ 3 mm by TEE or ICE after implantation of the LAA occluder.	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	Ischemic stroke, systemic embolism, and cardiac death events	24 months
(4)Perioperative (7 days after operation or before discharge) surgery-related complications	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	7 days
Procedure-related complications during follow-up	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	24 months
Occluder defects during operation and in the 3rd month after operation	Including but not limited: Occluder displacement, Occluder detachment, Occluder breakage, Occluder damage, etc	3 months
Incidence rate of severe adverse events within 24 months after operation	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	24 months

Collaborators and Investigators

• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
• Investigators: Principal Investigator: Chenyang Jiang, Doctor, Sir Run Run Shaw Hospital; Principal Investigator: Jinhua Zhang, Doctor, Sir Run Run Shaw Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2020
• Primary Completion (Anticipated): November 1, 2025
• Study Completion (Anticipated): November 1, 2027

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 20, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Left Atrial Appendage Closure; non-valvular atrial fibrillation; AF-related embolic events
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arrhythmias, Cardiac; Stroke; Ischemic Stroke; Atrial Fibrillation; Embolic Stroke
• Other Study ID Numbers: LAAC-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No