LAMax Vs. Watchman LAAC Device for Subjects With Non-valvular AF to Reduce the Risk of Stroke

May 4, 2022 updated by: Jian'an Wang,MD,PhD, Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective, Multicenter, Randomized, Active Controlled, Clinical Trial of the LAMax LAA Closure System Compared to the Watchman® LAAC Device for Subjects With Non-valvular Atrial Fibrillation to Reduce the Risk of Ischemic Stroke

This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage (LAA) Closure System.

Study Overview

Status

Status

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

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

This is a prospective, multicenter, randomized, active controlled, clinical trial to evaluate the safety and effectiveness of the LAMax Left Atrial Appendage Closure (LAAC) System. Subjects with non-valvular Atrial Fibrillation will be randomized in a 1:1 ratio to the Experimental Treatment Arm (LAMax LAAC system) or the Control Arm (Watchman LAAC system, Boston Scientific Inc., USA). The trial is designed to demonstrate that safety and effectiveness of the LAMax device are non-inferior to the Watchman device.

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.
Interventional

Enrollment (Actual)

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.
236

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
      • Beijing, China, 100039
        • The Third Medical Center, Chinese People's Liberation Army General Hospital
      • Chongqing, China, 400010
        • The Second Affiliated Hospital of Chongqing Medical University
      • Shanghai, China, 200011
        • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
      • Tianjin, China, 300020
        • General Hospital of Tianjin Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
    • Hebei
      • Shijiazhuang, Hebei, China, 050003
        • The Second Hospital of Hebei Medical University
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341001
        • Ganzhou Municipal Hospital
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330000
        • The Second Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Ningbo, Zhejiang, China, 315010
        • The First Municipal hospital of Ningbo

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

Description

Inclusion Criteria:

  • Patients ≥ 18 years old with non-valvular atrial fibrillation (AF) and CHA2DS2-VASc ≥2
  • There is one of the following: (1) Not suitable for long-term standard anticoagulation treatment; (2) On the basis of long-term standardized anticoagulant therapy with warfarin, stroke or embolism still occurred; (3) HAS-BLED ≥ 3.
  • Provide written informed consent and agree to comply with required follow-ups.

Exclusion Criteria:

  1. . Patients with other diseases other than AF who need long-term warfarin anticoagulation therapy;
  2. . Those who need selective cardiac surgery;
  3. . Heart failure NYHA grade IV;
  4. . AF caused by rheumatic valvular disease, degenerative valvular disease, congenital valvular disease, severe mitral stenosis, aortic stenosis, or other valvular diseases;
  5. . The early onset of AF and paroxysmal AF with definite causes, such as secondary to coronary artery bypass grafting (CABG), hyperthyroidism;
  6. . Patients with symptomatic carotid artery disease (such as carotid stenosis > 50%);
  7. . Patients with acute myocardial infarction, unstable angina, or recent myocardial infarction < 3 months;
  8. . Stroke or TIA within 30 days;
  9. . Bleeding disease, coagulation-related diseases, and active peptic ulcer;
  10. . Active endocarditis, vegetations, or other infections causing bacteremia or sepsis;
  11. . Conditions may lead to difficulty in testing or significantly shorten the life expectancy of patients (< 1 year);
  12. . Pregnant, lactating or planned pregnancy during the trial;
  13. . Patients who have not reached the end of other clinical trials of drug or device;
  14. . Hematological abnormality (WBC < 3 × 109 / L, HB < 90g / L, or platelet count < 50 × 109 / L or > 700 × 109 / L));
  15. . Renal insufficiency (creatinine > 3.0mg/dl or 265.2umoi / L), and / or advanced renal diseases requiring dialysis;
  16. . Severe liver dysfunction (AST / ALT is 5 times higher than the upper limit of normal value, or total bilirubin is 2 times higher than the upper limit of normal value);
  17. . The investigator believes that the patient is not suitable to participate in the clinical trial.
  18. . Left atrial appendage has been removed, post heart transplantation, post atrial septal repair, or post occluder implantation;
  19. . Radiofrequency ablation in 30 days before and after the implantation of LAA occluder;
  20. . Cardioversion within 30 days after the implantation of LAA occluder;
  21. . Post prosthetic heart valve replacement;
  22. . Allergic to or contraindication to metal nickel alloy, aspirin, clopidogrel, contrast agent, heparin and other anticoagulants, etc;
  23. . Patients who have placed other instruments in the cardiovascular cavity and are unable to place the LAA occluder;
  24. . LVEF（left ventricular ejection fraction ）<35%；
  25. . Clear thrombus is found in the heart before device implantation;
  26. . TEE examination: refer to Watchman LAAC requirement to measure the orifice diameter of LAA, the maximum diameter is less than 17 mm, or more than 31 mm;
  27. . Patent foramen ovale with high risk;
  28. . mitral stenosis with a valve area ≤ 2 cm2;
  29. . left atrial diameter > 65mm, or pericardial effusion more than a small amount, the depth of local effusion > 10 mm;
  30. . Contraindications to X-ray, or not suitable for TEE examination.

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: LAMax left atrial appendage occluder
Intervention device, LAMax left atrial appendage closure system
Device: Percutaneous left atrial appendage closure-LAMax
Interventional device, LAMax left atrial appendage closure system
Active Comparator: Watchman (control)
Intervention device, Watchman® LAA Closure Device
Device: Percutaneous left atrial appendage closure-Watchman
Interventional device, Watchman® LAA Closure Device

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
Successful sealing of the LAA
Time Frame: 12 months post-implantation
A composite rate of successful sealing of the left atrial appendage (defined as residual flow ≤ 5 mm) at the 12-month visit documented by transesophageal echocardiogram (TEE).
12 months post-implantation
Ischemic stroke, TIA, or Systemic embolism
Time Frame: 12 months post-implantation
A composite rate of ischemic stroke, TIA or systemic embolism.
12 months post-implantation

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
All stroke, systemic embolism, or cardiovascular/unexplained death
Time Frame: 12 months post-implantation
A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.
12 months post-implantation
Incidence of MACCE events
Time Frame: 12 months post-implantation
A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.
12 months post-implantation
Major Bleeding post-device implant
Time Frame: 12 months post-implantation
Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.
12 months post-implantation
Success rate of device collapse and reposition during implantation procedure
Time Frame: 0 day
It is one of the measures to describe device performance during implantation procedure.
0 day
Rate of cardiac temponade during implantation procedure
Time Frame: 0 day
It is one of the measures to describe the performance of device and delivery system during implantation procedure.
0 day
Success rate of delivering an occlusion device to the LAA by the delivery system
Time Frame: 0 day
It is one of the measures to describe the performance of delivery system during implantation procedure.
0 day
Success rate of withdrawing a delivery system after LAAC
Time Frame: 0 day
It is one of the measures to describe the performance of delivery system.
0 day
Device performance post-implantation
Time Frame: 12 months post-implantation
A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.
12 months post-implantation
Device success rate
Time Frame: 0 day
A composite rate to describe that the device can be successfully delivered in place and successfully implanted, and angiography shows that the implanted device is in the right position, no residual flow or residual flow is less than 5 mm, and the delivery system can be successfully withdrawn.
0 day
Perioperative clinical success rate
Time Frame: 7 days post-implantation
A composite rate to describe that the device's function is normal, including that it was successfully implanted, the residual flow was less than 5mm, the implanted device had no effect on mitral valve movement and pulmonary vein blood flow, and there was no major adverse event (MAE) at the time of discharge.
7 days post-implantation

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.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
LanZhou University
The Second Hospital of Hebei Medical University
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
The First Hospital of Jilin University
The Second Affiliated Hospital of Chongqing Medical University
Second Affiliated Hospital of Nanchang University
First Affiliated Hospital of Guangxi Medical University
The Third Medical Center, Chinese People's Liberation Army General Hospital
Ganzhou Municipal Hospital
The First Municipal hospital of Ningbo
General Hospital of Tianjin Medical University
ShenZhen KYD Biomedical Technology 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: Dongxing Ma, MD, The Third Medical Center, Chinese People's Liberation Army General 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.
April 20, 2019

Primary Completion (Actual)

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 11, 2020

Study Completion (Actual)

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.
June 10, 2021

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).
June 6, 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.
June 11, 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.
June 12, 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.
May 6, 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.
May 4, 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.
May 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.
  • SAHZJU CT019

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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