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Non-valvular Atrial FibrillationNCT04429646

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

A study testing Percutaneous left atrial appendage closure-LAMax and Percutaneous left atrial appendage closure-Watchman in people with Non-valvular Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 12 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-valvular Atrial Fibrillation
What is being tested?
Percutaneous left atrial appendage closure-LAMax and Percutaneous left atrial appendage closure-Watchman
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
12 sitesChina
Study dates
20 Apr 2019to 10 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • The Third Medical Center, Chinese People's Liberation Army General Hospital

    Beijing, 100039

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010

  • Ganzhou Municipal Hospital

    Ganzhou, Jiangxi, 341001

  • The Second Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The First Municipal hospital of Ningbo

    Ningbo, Zhejiang, 315010

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai, 200011

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050003

  • General Hospital of Tianjin Medical University

    Tianjin, 300020

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Percutaneous left atrial appendage closure-LAMax, Percutaneous left atrial appendage closure-Watchman
Keywords
Atrial Fibrillation, Left Atrial Appendage Closure, Ischemic Stroke
Medical subject headings
Atrial Fibrillation, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous left atrial appendage closure-LAMaxDevice

    Interventional device, LAMax left atrial appendage closure system

  • Percutaneous left atrial appendage closure-WatchmanDevice

    Interventional device, Watchman® LAA Closure Device

Study groups in NCT04429646
Study groupRoleWhat they receive
LAMax left atrial appendage occluderExperimentalIntervention device, LAMax left atrial appendage closure system
Receives: Device: Percutaneous left atrial appendage closure-LAMax
Watchman (control)Active comparatorIntervention device, Watchman® LAA Closure Device
Receives: Device: Percutaneous left atrial appendage closure-Watchman

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful sealing of the LAA

    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).

    Measured: 12 months post-implantation

  2. Ischemic stroke, TIA, or Systemic embolism

    A composite rate of ischemic stroke, TIA or systemic embolism.

    Measured: 12 months post-implantation

Secondary outcomes (10)

  1. All stroke, systemic embolism, or cardiovascular/unexplained death

    A composite rate of all stroke, systemic embolism, or cardiovascular/unexplained death.

    Measured: 12 months post-implantation

  2. Incidence of MACCE events

    A composite rate of MACCE, includes all-cause mortality, stroke, device embolism, cardiac tamponade.

    Measured: 12 months post-implantation

  3. Major Bleeding post-device implant

    Major bleeding rate at 12 months post-implant: defined as Type 3a or greater based on the Bleeding Academic Research Consortium (BARC) definition.

    Measured: 12 months post-implantation

  4. Success rate of device collapse and reposition during implantation procedure

    It is one of the measures to describe device performance during implantation procedure.

    Measured: 0 day

  5. Rate of cardiac temponade during implantation procedure

    It is one of the measures to describe the performance of device and delivery system during implantation procedure.

    Measured: 0 day

  6. Success rate of delivering an occlusion device to the LAA by the delivery system

    It is one of the measures to describe the performance of delivery system during implantation procedure.

    Measured: 0 day

  7. Success rate of withdrawing a delivery system after LAAC

    It is one of the measures to describe the performance of delivery system.

    Measured: 0 day

  8. Device performance post-implantation

    A composite rate of device migration, embolization, regurgitation, perivalvular leak post-implantation.

    Measured: 12 months post-implantation

  9. Device success rate

    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.

    Measured: 0 day

  10. Perioperative clinical success rate

    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.

    Measured: 7 days post-implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2020
  2. Study start20 Apr 2019
  3. Primary completion11 Nov 2020
  4. Study completion10 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label
Masking
None (open label)
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04429646
Sponsor's protocol ID
SAHZJU CT019
Status last verified
May 2022
First submitted
6 Jun 2020
Last updated
6 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fan Y, Ma D, Wang C, Luo J, Ling Z, Li S, Peng X, Zhang Z, Chu H, Wang J; investigators in the present study. A Membrane Modification Technique for Left Atrial Appendage Occlusion: A Multicenter Randomized Controlled Trial. JACC Asia. 2025 Mar;5(3 Pt 1):374-387. doi: 10.1016/j.jacasi.2024.12.008. Epub 2025 Feb 18.

    PubMed 40049930

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous left atrial appendage closure-LAMax and Percutaneous left atrial appendage closure-Watchman in people with Non-valvular Atrial Fibrillation, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful sealing of the LAA (time frame: 12 months post-implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04429646, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2022.

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