NCT04429646

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2021

Completed
Last Updated

May 6, 2022

Status Verified

May 1, 2022

Enrollment Period

1.6 years

First QC Date

June 6, 2020

Last Update Submit

May 4, 2022

Conditions

Non-valvular Atrial Fibrillation

Keywords

Atrial FibrillationLeft Atrial Appendage ClosureIschemic Stroke

Outcome Measures

Primary Outcomes (2)

  • 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).

    12 months post-implantation

  • Ischemic stroke, TIA, or Systemic embolism

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

    12 months post-implantation

Secondary Outcomes (10)

  • All stroke, systemic embolism, or cardiovascular/unexplained death

    12 months post-implantation

  • Incidence of MACCE events

    12 months post-implantation

  • Major Bleeding post-device implant

    12 months post-implantation

  • Success rate of device collapse and reposition during implantation procedure

    0 day

  • Rate of cardiac temponade during implantation procedure

    0 day

  • +5 more secondary outcomes

Study Arms (2)

LAMax left atrial appendage occluder

EXPERIMENTAL

Intervention device, LAMax left atrial appendage closure system

Device: Percutaneous left atrial appendage closure-LAMax

Watchman (control)

ACTIVE COMPARATOR

Intervention device, Watchman® LAA Closure Device

Device: Percutaneous left atrial appendage closure-Watchman

Interventions

Percutaneous left atrial appendage closure-LAMaxDEVICE

Interventional device, LAMax left atrial appendage closure system

LAMax left atrial appendage occluder
Percutaneous left atrial appendage closure-WatchmanDEVICE

Interventional device, Watchman® LAA Closure Device

Watchman (control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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%);
  • 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;
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050003, China

Location

Ganzhou Municipal Hospital

Ganzhou, Jiangxi, 341001, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

The First Municipal hospital of Ningbo

Ningbo, Zhejiang, 315010, China

Location

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

Beijing, 100039, China

Location

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

Location

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

Shanghai, 200011, China

Location

General Hospital of Tianjin Medical University

Tianjin, 300020, China

Location

Related Publications (1)

  • 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.

    PMID: 40049930DERIVED

MeSH Terms

Conditions

Atrial FibrillationIschemic Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsStrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Jian-an Wang, MD, PhD

    Second Affiliated Hospital, School of Medicine, Zhejiang University

    PRINCIPAL INVESTIGATOR

  • Dongxing Ma, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Prevention Endpoint Classification: Safety/Efficacy Study Masking: Open Label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President of the Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 12, 2020

Study Start

April 20, 2019

Primary Completion

November 11, 2020

Study Completion

June 10, 2021

Last Updated

May 6, 2022

Record last verified: 2022-05

Locations

CN(12)