A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
NCT ID: NCT06168942
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
1500 participants
INTERVENTIONAL
2024-02-19
2032-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Laminar Device
Participants will be treated with the Laminar Left Atrial Appendage Closure System.
Experimental: Laminar Left Atrial Appendage Closure System
Treatment with the Laminar Left Atrial Appendage Closure System.
Control left atrial appendage closure (LAAC)
Participants will be treated with a commercially-available LAAC device.
Active Comparator: WATCHMAN / Amulet
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.
Interventions
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Experimental: Laminar Left Atrial Appendage Closure System
Treatment with the Laminar Left Atrial Appendage Closure System.
Active Comparator: WATCHMAN / Amulet
Treatment with a WATCHMAN left atrial appendage closure device / Amulet left atrial appendage occluder.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Biosense Webster, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Saibal Kar, MD
Role: PRINCIPAL_INVESTIGATOR
Los Robles Health System
Devi Nair, MD
Role: PRINCIPAL_INVESTIGATOR
St. Bernards Heart and Vascular Center
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
Arizona Arrhythmia Research Group Phoenix Cardio Research Group PCRG
Phoenix, Arizona, United States
Tucson Medical Center
Tucson, Arizona, United States
Arrhythmia Research Group
Jonesboro, Arkansas, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Stanford Health Care
Palo Alto, California, United States
Univeristy of California Davis Health
Rancho Cordova, California, United States
Scripps Health
San Diego, California, United States
Providence Saint John's Health Center and the Pacific Heart Institute
Santa Monica, California, United States
Los Robles Regional Medical Center
Thousand Oaks, California, United States
NCH Healthcare
North Naples, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University
Atlanta, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
The Kansas City Heart Rhythm Institute
Overland Park, Kansas, United States
Ascension via Christi Hospitals Wichita Inc
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Englewood Health
Englewood, New Jersey, United States
Northwell Health
Bay Shore, New York, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University in the City of New York and The New York and Presbyterian Hospital
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Wake Forest University Health Sciences
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
Bethesda North Hospital Trihealth
Cincinnati, Ohio, United States
Lindner Clinical Trial Center/Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Ohio Health
Columbus, Ohio, United States
Trident Medical Center
North Charleston, South Carolina, United States
Centennial Medical Center
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Texas Heart Institute
Houston, Texas, United States
Baylor Scott & White Research Institute at The Heart Hospital Baylor Plano
Plano, Texas, United States
Heart Rhythm Associates
Shenandoah, Texas, United States
Swedish Medical Center
Seattle, Washington, United States
St Joseph Hospital and Medical Center
Tacoma, Washington, United States
Mercy Hospital
Janesville, Wisconsin, United States
AZORG campus Aalst Moorselbaan
Aalst, , Belgium
AZ Sint Jan Brugge Oostende AV
Bruges, , Belgium
C.H.U. Brugmann
Brussels, , Belgium
CHU Charleroi Chimay
Charleroi, , Belgium
Nemocnice na Homolce
Prague, , Czechia
Rigshospitalet Copenhagen University Hospital
Copenhagen, , Denmark
Hopital Prive Jacques Cartier
Massy, , France
Clinique Pasteur
Toulouse, , France
MVZ CCB Frankfurt und Main Taunus GbR
Frankfurt a.M., , Germany
CVC CardioVascular Center Frankfurt
Frankfurt am Main, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Asklepios Klinik Altona
Hamburg, , Germany
Fondazione Toscana Gabriele Monasterio CNR
Massa, , Italy
Centro Cardiologico Monzino
Milan, , Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Policlinico Tor Vergata
Roma, , Italy
Vilnius University Hospital Santaros Clinics
Vilnius, , Lithuania
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, , Poland
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Clinico San Carlos
Madrid, , Spain
Clinica Univ. de Navarra
Pamplona, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hosp. Alvaro Cunqueiro
Vigo, , Spain
Countries
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Other Identifiers
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LAM202403
Identifier Type: OTHER
Identifier Source: secondary_id
CL-0059
Identifier Type: OTHER
Identifier Source: secondary_id
LAM202403
Identifier Type: -
Identifier Source: org_study_id