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

December 15, 2022 updated by: Lifetech Scientific (Shenzhen) Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
579

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • 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:
        • Principal Investigator:
          • Zhang Dayong, Doctor
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325600
        • Recruiting
        • The First Affiliated Hospital of WMU
        • Contact:
        • Principal Investigator:
          • Huang Weijian, Doctor
      • Wenzhou, Zhejiang, China, 325600
        • Recruiting
        • The Second Affiliated Hospital and Yuying Children's Hospital of WMU
        • Contact:
        • Principal Investigator:
          • Li Yuechun, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: 12 months
Bleeding events
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Surgical success rate
Time Frame: 24 months
Surgical success
24 months
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 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
Time Frame: 24 months
Ischemic stroke, systemic embolism, and cardiac death events
24 months
(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
7 days
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
24 months
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
3 months
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lifetech Scientific (Shenzhen) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chenyang Jiang, Doctor, Sir Run Run Shaw Hospital
  • Principal Investigator: Jinhua Zhang, Doctor, Sir Run Run Shaw Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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