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A Pivotal Investigational Device Exemption Study on Laminar Left Atrial Appendage Elimination
Sponsor: Biosense Webster, Inc.
Summary
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).
Official title: Laminar Left Atrial Appendage Elimination (LAAX) Pivotal IDE Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1500
Start Date
2024-02-19
Completion Date
2032-02-29
Last Updated
2026-05-08
Healthy Volunteers
No
Interventions
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.
Locations (71)
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
OC Medical Center
Fountain Valley, California, 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
St Vincents Medical Center 1
Jacksonville, Florida, 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