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

NCT04429646 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2022-05-06

No results posted yet for this study

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.

Conditions

  • Non-valvular Atrial Fibrillation

Interventions

DEVICE

Percutaneous left atrial appendage closure-LAMax

Interventional device, LAMax left atrial appendage closure system

DEVICE

Percutaneous left atrial appendage closure-Watchman

Interventional device, Watchman® LAA Closure Device

Sponsors & Collaborators

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

    collaborator UNKNOWN

  • The Second Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Ganzhou Municipal Hospital

    collaborator UNKNOWN

  • First Affiliated Hospital of Guangxi Medical University

    collaborator OTHER

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • LanZhou University

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • The First Affiliated Hospital of Nanchang University

    collaborator OTHER

  • The First Municipal hospital of Ningbo

    collaborator UNKNOWN

  • Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    collaborator OTHER

  • Tianjin Medical University General Hospital

    collaborator OTHER

  • ShenZhen KYD Biomedical Technology Co., Ltd.

    collaborator INDUSTRY

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Jian-an Wang, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

  • Dongxing Ma, MD · The Third Medical Center, Chinese People's Liberation Army General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-20
Primary Completion
2020-11-11
Completion
2021-06-10

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04429646 on ClinicalTrials.gov