此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

层流 LAAX Pivotal IDE 研究

2026年10月14日 更新者：Jaguar LAA, Inc.

层流左心耳消除 (LAAX) 关键 IDE 研究

The purpose of this study is to compare the safety and effectiveness of Laminar Left Atrial Appendage Closure (LAAC) device as compared to the commercially available LAAC devices in participants with non-valvular atrial fibrillation (NVAF) to reduce the risk of stroke (blocked blood vessel or bleeding in brain) and systemic embolism (blockage in a blood vessel harming vital organs).

研究概览

地位

暂停

条件

干预/治疗

详细说明

This prospective, randomized, controlled, multicenter, open-label pivotal clinical study will enroll participants with non-valvular atrial fibrillation who are eligible for short-term anticoagulation therapy but have a rationale to seek non-pharmacologic alternative. Participants will be randomized 1:1 to the Laminar Left Atrial Appendage Closure System or commercially available device (WATCHMAN™ left atrial appendage closure device / Amulet™ left atrial appendage occluder).

研究类型

介入性

注册 (估计的)

1500

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35243
        • Grandview Medical Center
    • Arizona
      • Phoenix、Arizona、美国、85018
        • Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
      • Tucson、Arizona、美国、85712
        • Tucson Medical Center
    • Arkansas
      • Jonesboro、Arkansas、美国、72401
        • Arrhythmia Research Group
    • California
      • Los Angeles、California、美国、90048
        • Cedars Sinai Medical Center
      • Palo Alto、California、美国、94303
        • Stanford Health Care
      • Rancho Cordova、California、美国、95670
        • Univeristy of California Davis Health
      • San Diego、California、美国、92121
        • Scripps Health
      • Santa Monica、California、美国、90404
        • Providence Saint John's Health Center and the Pacific Heart Institute
      • Thousand Oaks、California、美国、91360
        • Los Robles Regional Medical Center
    • Florida
      • North Naples、Florida、美国、34102
        • NCH Healthcare
      • Sarasota、Florida、美国、34239
        • Sarasota Memorial Hospital
    • Georgia
      • Atlanta、Georgia、美国、30322
        • Emory University
      • Atlanta、Georgia、美国、30309
        • Piedmont Healthcare
      • Savannah、Georgia、美国、31404
        • Memorial Health University Medical Center
    • Kansas
      • Overland Park、Kansas、美国、66211
        • The Kansas City Heart Rhythm Institute
      • Wichita、Kansas、美国、67214
        • Ascension via Christi Hospitals Wichita Inc
    • Kentucky
      • Lexington、Kentucky、美国、40503
        • Baptist Health Lexington
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • Massachusetts General Hospital
    • New York
      • Bay Shore、New York、美国、11706
        • Northwell Health
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai
      • New York、New York、美国、10016
        • NYU Langone Health
      • New York、New York、美国、10032
        • Columbia University in the City of New York and The New York and Presbyterian Hospital
      • The Bronx、New York、美国、10467
        • Montefiore Medical Center
    • North Carolina
      • Charlotte、North Carolina、美国、28203
        • Wake Forest University Health Sciences
    • Ohio
      • Cincinnati、Ohio、美国、45219
        • Lindner Clinical Trial Center/Christ Hospital
      • Cincinnati、Ohio、美国、45202
        • Bethesda North Hospital Trihealth
      • Columbus、Ohio、美国、43210
        • Ohio State University
      • Columbus、Ohio、美国、43214
        • Ohio Health
    • South Carolina
      • North Charleston、South Carolina、美国、29406
        • Trident Medical Center
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center
      • Nashville、Tennessee、美国、37203
        • Centennial Medical Center
    • Texas
      • Austin、Texas、美国、78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Shenandoah、Texas、美国、77380
        • Heart Rhythm Associates
    • Washington
      • Seattle、Washington、美国、98122
        • Swedish Medical Center
      • Tacoma、Washington、美国、98405
        • St Joseph Hospital and Medical Center

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Documented evidence of paroxysmal, persistent, or permanent non-valvular atrial fibrillation (NVAF)
  • CHA2DS2-VASc score greater than or equal to (>=) 2 in men and >= 3 in women
  • Deemed to be clinically indicated for left atrial appendage (LAA) closure by the Site Investigator and a clinician not a part of the procedural team using an evidence-based decision-making tool in accordance with standard of care
  • Recommended for chronic oral anticoagulation therapy (OAC) but has an appropriate rationale to seek a non-pharmacologic alternative
  • Eligible for the protocol-specified post-procedural antithrombotic regimen
  • Willing and able to comply with the protocol, and has provided written informed consent (participant or legally authorized representative) per institutional review board (IRB) requirements

Exclusion Criteria:

  • Single episode, transient, or reversible atrial fibrillation (AF) (example, secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
  • Prior cardiac surgery or any procedure that involved pericardial access
  • Stage IV kidney disease or Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) less than (<) 30 milliliters per minute per (mL/min)/1.73 square meters (m^2) or participants with end stage renal disease who are dialysis dependent
  • Any cardiac or non-cardiac interventional or surgical procedures within 60 days prior to or any planned general surgery, cardiac surgery, or interventional procedure within 60 days after implant (including, but not limited to cardioversion, percutaneous coronary intervention (PCI), cardiac ablation, cataract surgery)
  • Left atrial appendage anatomy which cannot accommodate either commercially available control device or the laminar implant per manufacturer instructions for use (IFU) (that is, the anatomy and sizing must be appropriate for a control and the Laminar device to be enrolled in the study)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Laminar Device

Participants will be treated with the Laminar Left Atrial Appendage Closure System.
设备：Experimental: Laminar Left Atrial Appendage Closure System

Treatment with the Laminar Left Atrial Appendage Closure System.
有源比较器：Control left atrial appendage closure (LAAC)

Participants will be treated with a commercially-available LAAC device.
设备：Active Comparator: WATCHMAN / Amulet

Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
All-Cause Mortality
大体时间：Up to 12 months

Composite rate of all-cause mortality will be reported.
Up to 12 months
Number of Participants With Major Bleeding According to the Bleeding Academic Research Consortium (BARC) Type III or V
大体时间：Up to 12 months

The number of participants with major bleeding, according to the BARC type III or V, will be reported.

Type III

  1. Type IIIa includes overt bleeding plus a hemoglobin drop of 3 to less than (<) 5 grams per deciliter (g/dL) related to bleeding and any transfusion with overt bleeding.
  2. Type IIIb involves overt bleeding plus a hemoglobin drop of greater than or equal to (>=) 5 g/dL related to bleeding, cardiac tamponade, bleeding requiring surgical intervention for control, or bleeding requiring intravenous vasoactive agents.
  3. Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision.

Type V

  1. Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
  2. Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.
Up to 12 months
Number of Participants With Pericardial Effusion Requiring Drainage
大体时间：Up to 12 months

Participants with pericardial effusion requiring drainage will be reported. Pericardial effusion is defined as 1) Clinically non-relevant: requiring no intervention, treated pharmacologically and 2) Clinically relevant: treated with therapeutic intervention (pericardiocentesis, surgical intervention, blood transfusion) and/or result in shock or death.
Up to 12 months
Number of Participants With Device Embolization
大体时间：Up to 12 months

Participants with device embolization will be reported. Device embolization is defined as movement of a medical device to an unintended location within the body with resulting obstruction of an organ or vessel.
Up to 12 months
Number of Participants With Device or Procedure-Related Events Requiring Open Cardiac Surgery or Major Endovascular Intervention
大体时间：Up to 12 Months

Participants with device or procedure-related events requiring open cardiac surgery or major endovascular intervention will be reported.
Up to 12 Months
Number of Participants Reporting Ischemic Stroke or Systemic Embolism
大体时间：Up to 18 Months

Participant reporting ischemic stroke or systemic embolism will be reported. Systemic embolism is defined as acute vascular insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (example; trauma, atherosclerosis, or instrumentation).
Up to 18 Months

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With Peri-Device Flow
大体时间：Up to 12 Months

Peri-Device flow is defined as >= 3 mm in width which communicates beyond the device into the body of the left atrial appendage) per transesophageal echocardiogram (TEE) evaluated by independent core laboratory.
Up to 12 Months
Rate of Device-Related Thrombosis
大体时间：Up to 12 Months

Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.
Up to 12 Months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Jaguar LAA, Inc.

调查人员

  • 首席研究员：Saibal Kar, MD、Los Robles Health System
  • 首席研究员：Devi Nair, MD、St. Bernards Heart and Vascular Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年2月19日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2032年2月29日

研究注册日期

首次提交

2023年12月5日

首先提交符合 QC 标准的

2023年12月5日

首次发布 (实际的)

2023年12月13日

研究记录更新

最后更新发布 (实际的)

2026年10月19日

上次提交的符合 QC 标准的更新

2026年10月14日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • LAM202403
  • CL-0059 (其他标识符：Laminar, Inc.)
  • LAM202403 (其他标识符：Biosense Webster, Inc.)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅