A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination

Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study

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).

Study Overview

• Status: Suspended
• Conditions: Stroke; Non-valvular Atrial Fibrillation; Systemic Embolism
• Intervention / Treatment: Device: Experimental: Laminar Left Atrial Appendage Closure System; Device: Active Comparator: WATCHMAN / Amulet

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • AZORG campus Aalst Moorselbaan
  • Bruges, Belgium, 8000
    • AZ Sint Jan Brugge Oostende AV
  • Brussels, Belgium, 1020
    • C.H.U. Brugmann
  • Charleroi, Belgium, 6042
    • CHU Charleroi Chimay
• Czechia
  • Prague, Czechia, 150 30 District 5
    • Nemocnice Na Homolce
• Denmark
  • Copenhagen, Denmark, 2100
    • Rigshospitalet Copenhagen University Hospital
• France
  • Massy, France, 91300
    • Hôpital privé Jacques Cartier
  • Toulouse, France, 31300
    • Clinique Pasteur
• Germany
  • Frankfurt a.M., Germany, 60431
    • MVZ CCB Frankfurt und Main Taunus GbR
  • Frankfurt am Main, Germany, 60389
    • CVC CardioVascular Center Frankfurt
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona
  • Hamburg, Germany, 22587
    • Asklepios Klinik St. Georg
• Italy
  • Massa, Italy, 54100
    • Fondazione Toscana Gabriele Monasterio CNR
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino
  • Milan, Italy, 20162
    • ASST Grande Ospedale Metropolitano Niguarda
  • Roma, Italy, 00133
    • Policlinico Tor Vergata
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Clinics
• Netherlands
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis Nieuwegein
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
• Poland
  • Poznan, Poland, 61 848
    • Uniwersytecki Szpital Kliniczny w Poznaniu
• Spain
  • Barcelona, Spain, 08025
    • Hosp. de La Santa Creu I Sant Pau
  • Barcelona, Spain, 08036
    • Hosp Clinic de Barcelona
  • Madrid, Spain, 28040
    • Hosp. Clinico San Carlos
  • Pamplona, Spain, 31008
    • Clinica Univ. de Navarra
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca
  • Vigo, Spain, 36213
    • Hosp. Alvaro Cunqueiro
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Grandview Medical Center
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
    • Tucson, Arizona, United States, 85712
      • Tucson Medical Center
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • Arrhythmia Research Group
  • California
    • Fountain Valley, California, United States, 92708
      • OC Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Palo Alto, California, United States, 94303
      • Stanford Health Care
    • Rancho Cordova, California, United States, 95670
      • Univeristy of California Davis Health
    • San Diego, California, United States, 92121
      • Scripps Health
    • Santa Monica, California, United States, 90404
      • Providence Saint John's Health Center and the Pacific Heart Institute
    • Thousand Oaks, California, United States, 91360
      • Los Robles Regional Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St Vincents Medical Center 1
    • North Naples, Florida, United States, 34102
      • NCH Healthcare
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Healthcare
    • Savannah, Georgia, United States, 31404
      • Memorial Health University Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • The Kansas City Heart Rhythm Institute
    • Wichita, Kansas, United States, 67214
      • Ascension via Christi Hospitals Wichita Inc
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Columbia University in the City of New York and The New York and Presbyterian Hospital
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Wake Forest University Health Sciences
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Lindner Clinical Trial Center/Christ Hospital
    • Cincinnati, Ohio, United States, 45202
      • Bethesda North Hospital Trihealth
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University
    • Columbus, Ohio, United States, 43214
      • Ohio Health
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Trident Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37203
      • Centennial Medical Center
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • Texas Heart Institute
    • Plano, Texas, United States, 75093
      • Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
    • Shenandoah, Texas, United States, 77380
      • Heart Rhythm Associates
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center
    • Tacoma, Washington, United States, 98405
      • St Joseph Hospital and Medical Center
  • Wisconsin
    • Janesville, Wisconsin, United States, 53548
      • Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laminar Device; Participants will be treated with the Laminar Left Atrial Appendage Closure System.	Device: Experimental: Laminar Left Atrial Appendage Closure System; Treatment with the Laminar Left Atrial Appendage Closure System.
Active Comparator: Control left atrial appendage closure (LAAC); Participants will be treated with a commercially-available LAAC device.	Device: Active Comparator: WATCHMAN / Amulet; Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality	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	The number of participants with major bleeding, according to the BARC type III or V, will be reported. Type III; 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.; 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.; Type IIIc includes intracranial hemorrhage, with subcategories confirmed by autopsy, imaging, or lumbar puncture, as well as intraocular bleeding compromising vision. Type V; Type Va: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.; Type Vb: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation.	Up to 12 months
Number of Participants With Pericardial Effusion Requiring Drainage	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	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Peri-Device Flow	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	Device related thrombosis is defined as density attached to the implanted LAAC device in echocardiographic or computer tomography imaging.	Up to 12 Months

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Collaborators: Cardiovascular Research Foundation, New York
• Investigators: Principal Investigator: Saibal Kar, MD, Los Robles Health System; Principal Investigator: Devi Nair, MD, St. Bernards Heart and Vascular Center

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 29, 2032

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 13, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: LAM202403 (Other Identifier: Biosense Webster, Inc.); CL-0059 (Other Identifier: Laminar, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No