Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
- Conditions
- Ischemic StrokeSystemic Embolism
- Interventions
- Device: AtriClip LAA Exclusion System
- Registration Number
- NCT05478304
- Lead Sponsor
- AtriCure, Inc.
- Brief Summary
This trial is a prospective, randomized, multicenter, multinational, blinded, superiority trial. The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 6500
-
Subjects ≥ 18 years of age
-
Documentation of any of the following clinical criteria:
- CHA2DS2-VASc ≥ 4 with age ≥ 65
- CHA2DS2-VASc ≥ 4 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc = 3 with age ≥ 75
- CHA2DS2-VASc = 3 with significant left atrium enlargement or elevated NT-proBNP
- CHA2DS2-VASc score = 2 with age ≥ 65 and significant left atrium enlargement or elevated NT-proBNP
-
Clinically significant atrial fibrillation or atrial flutter:
- Anytime in the past and
- Documented by an electrocardiographic recording and
- Episode lasting 6 minutes or longer1*
-
Prior procedure involving opening the pericardium or entering the pericardial space
-
Prior LAA occlusion, exclusion, or removal (surgical or percutaneous)
-
Planned cardiac surgical procedure using non-sternotomy approaches
o Partial sternotomies will be allowed.
-
Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices
-
Active endocarditis
-
Active systemic infection at the time of cardiac surgery requiring antibiotics, including known SARS-CoV2 infections regardless of symptoms
-
Known allergy to Nitinol or nickel sensitivity
-
Known medical condition with expected survival of less than 1 year
-
Other comorbidities that in the investigator's opinion make the subject unsuitable candidate to complete the protocol required visits.
-
Current enrollment in an investigation or trial or an investigational devices or investigational drug that would interfere with this trial.
-
Mental impairment or other psychiatric conditions which may not allow the patient to understand the nature, significance, and scope of the trial.
-
Pregnancy
-
Known severe symptomatic carotid disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment AtriClip LAA Exclusion System LAAE using the AtriClip concomitant to and at the time of planned cardiac surgery
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint Common termination point (median follow-up for 5 years) Time to the first occurrence of ischemic stroke or systemic arterial embolism as adjudicated by the Clinical Events Committee (CEC), or any procedure wherein the LAA was excluded, occluded, or amputated following the index procedure.
Primary Safety Endpoint 30 days post index procedure Occurrence of at least one of the following events assessed through 30 days post index procedure:
* Pericardial effusion requiring percutaneous or surgical treatment
* Major bleeding attributable to index surgical procedure
* Deep sternal wound infection
* Myocardial infarction
- Secondary Outcome Measures
Name Time Method Powered Secondary Effectiveness endpoint Common termination point (median follow-up for 5 years) Time to the first occurrence of ischemic stroke or systemic arterial embolism
Trial Locations
- Locations (126)
Heart Center Research / Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
HonorHealth Shea Scottsdale Healthcare
🇺🇸Scottsdale, Arizona, United States
St. Bernard's Heart & Vascular
🇺🇸Jonesboro, Arkansas, United States
CHI St. Vincent
🇺🇸Little Rock, Arkansas, United States
Arkansas Heart Hospital
🇺🇸Little Rock, Arkansas, United States
Memorial Care Long Beach Medical Center
🇺🇸Long Beach, California, United States
Keck Medical Center of USC
🇺🇸Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Sutter Sacramento Hospital
🇺🇸Sacramento, California, United States
Stanford University
🇺🇸Stanford, California, United States
University of Colorado
🇺🇸Boulder, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
HCA Florida JFK Hospital
🇺🇸Atlantis, Florida, United States
HealthPark Medical Center
🇺🇸Fort Myers, Florida, United States
University of Florida Hospital
🇺🇸Gainesville, Florida, United States
Memorial Regional Hospital
🇺🇸Hollywood, Florida, United States
Baptist Health Jacksonville
🇺🇸Jacksonville, Florida, United States
Baptist Health South Florida
🇺🇸Miami, Florida, United States
Advent South
🇺🇸Orlando, Florida, United States
Orlando Regional Medical Center
🇺🇸Orlando, Florida, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Baycare Health System
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Wellstar - Kennestone
🇺🇸Marietta, Georgia, United States
St. Luke's Regional Medical Center
🇺🇸Boise, Idaho, United States
Portneuf Medical Center
🇺🇸Idaho Falls, Idaho, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Memorial Hospital (SIU Medicine)
🇺🇸Springfield, Illinois, United States
Ascension St. Vincent
🇺🇸Carmel, Indiana, United States
Franciscan
🇺🇸Indianapolis, Indiana, United States
Mercy Medical Center
🇺🇸Coon Rapids, Minnesota, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
St. Luke's Hospital
🇺🇸Kansas City, Kansas, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
Baptist Health
🇺🇸Lexington, Kentucky, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Norton Healthcare
🇺🇸Louisville, Kentucky, United States
University of Louisville Health / Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Novant Presbyterian Hospital
🇺🇸Louisville, Kentucky, United States
Our Lady of the Lake Hospital
🇺🇸Baton Rouge, Louisiana, United States
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Corewell Health
🇺🇸Grand Rapids, Michigan, United States
Corewell Health East
🇺🇸Royal Oak, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Trinity Health (formerly St. Joesph Mercy)
🇺🇸Ypsilanti, Michigan, United States
Abbott Northwestern / Minneapolis Heart
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
North Mississippi Medical Center
🇺🇸Tupelo, Mississippi, United States
Midwest Heart and Vascular (HCA)
🇺🇸Kansas City, Missouri, United States
St. Lukes Hospital
🇺🇸Saint Louis, Missouri, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Nebraska Methodist
🇺🇸Omaha, Nebraska, United States
The Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Rutgers Robert Woods Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
North Shore University Hospital (Northwell)
🇺🇸Manhasset, New York, United States
St. Francis Hospital
🇺🇸Roslyn, New York, United States
St. Joseph Hospital
🇺🇸Syracuse, New York, United States
Atrium Health Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
WakeMed Health & Hospitals
🇺🇸Raleigh, North Carolina, United States
Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
TriHealth / Bethesda North Hospital
🇺🇸Cincinnati, Ohio, United States
Christ Hospital / Lindner Research Center
🇺🇸Cincinnati, Ohio, United States
University Hospitals of Cleveland
🇺🇸Cleveland, Ohio, United States
Ohio State Medical Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist
🇺🇸Columbus, Ohio, United States
The Toledo Hospital (Promedica)
🇺🇸Toledo, Ohio, United States
Lehigh Valley Health Network
🇺🇸Allentown, Pennsylvania, United States
UPMC Pinnacle
🇺🇸Harrisburg, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Health System
🇺🇸Pittsburgh, Pennsylvania, United States
Lankenau Hospital
🇺🇸Wynnewood, Pennsylvania, United States
Medical University of South Carolina (MUSC)
🇺🇸Charleston, South Carolina, United States
Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Jackson Madison County General
🇺🇸Jackson, Tennessee, United States
Centennial Medical Center (TriStar)
🇺🇸Nashville, Tennessee, United States
Ascension St. Thomas West
🇺🇸Nashville, Tennessee, United States
UT Dell Medical School
🇺🇸Austin, Texas, United States
HCA Medical City Dallas
🇺🇸Dallas, Texas, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Baylor Heart Hospital - Plano
🇺🇸Plano, Texas, United States
Trinity Mother Frances (CHRISTUS)
🇺🇸Tyler, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Inova Fairfax Medical
🇺🇸Falls Church, Virginia, United States
Sentara Hospitals & Sentara Medical Group
🇺🇸Norfolk, Virginia, United States
Swedish Heart and Vascular Research
🇺🇸Seattle, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Columbia St. Mary's
🇺🇸Milwaukee, Wisconsin, United States
Aspirus Hospital
🇺🇸Wausau, Wisconsin, United States
University Hospitals UZ Leuven
🇧🇪Leuven, Brabant, Belgium
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
New Brunswick Heart Centre
🇨🇦Saint John, New Brunswick, Canada
Queen Elizabeth II - Nova Scotia Health
🇨🇦Halifax, Nova Scotia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
St Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Centre Hospitalier de l'Université de Montréal (CHUM)
🇨🇦Montréal, Quebec, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
IUCPQ Hosptial Laval
🇨🇦Québec, Canada
CKTCH Brno
🇨🇿Brno, Czechia
Bad Rothefelde Schüchtermann-Klinik
🇩🇪Bad Rothenfelde, Lower Saxony, Germany
Hospital Clinic Barcelona
🇪🇸Barcelona, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Northern General Hospital
🇬🇧Sheffield, Great Britain, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, North Yorkshire, United Kingdom
The Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, West Midlands, United Kingdom
Royal Papworth Hospital
🇬🇧Cambridge, United Kingdom