Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial
Launched by ATRICURE, INC. · Jul 26, 2022
Trial Information
Current as of July 25, 2025
Recruiting
Keywords
ClinConnect Summary
The Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial is a study designed to see if a specific procedure, called left atrial appendage exclusion (LAAE), can help prevent strokes in patients who are undergoing heart surgery and have certain risk factors for strokes and heart rhythm problems. This trial is currently recruiting participants aged 18 and older, particularly focusing on those who have a higher risk of stroke due to their age or heart conditions, as indicated by a scoring system called CHA2DS2-VASc.
To be eligible for the trial, participants must meet specific health criteria related to their age and heart health, such as being over 65 years old with a higher CHA2DS2-VASc score. However, individuals with certain heart conditions, previous heart surgeries, or other significant health issues may not qualify. Those who join the study will undergo the LAAE procedure and will be monitored to determine how effective it is in reducing the risk of strokes. This trial aims to provide valuable information that could help improve stroke prevention strategies for patients at risk.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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
- Exclusion Criteria:
- * 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
About Atricure, Inc.
AtriCure, Inc. is a leading medical device company focused on developing innovative solutions for the treatment of atrial fibrillation and other cardiac conditions. With a commitment to advancing cardiac surgery and improving patient outcomes, AtriCure specializes in technologies that address the complexities of heart rhythm disorders. The company's portfolio includes a range of devices and therapies designed to facilitate atrial fibrillation management and enhance surgical techniques. Through rigorous clinical trials and a dedication to research, AtriCure aims to provide healthcare professionals with effective tools to optimize patient care in the field of electrophysiology and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Ann Arbor, Michigan, United States
Boston, Massachusetts, United States
Lexington, Kentucky, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Toronto, Ontario, Canada
Iowa City, Iowa, United States
Boston, Massachusetts, United States
Maywood, Illinois, United States
Stanford, California, United States
Chicago, Illinois, United States
Sarasota, Florida, United States
Hackensack, New Jersey, United States
Edmonton, Alberta, Canada
Traverse City, Michigan, United States
Atlanta, Georgia, United States
Kingston, Ontario, Canada
Boise, Idaho, United States
Pittsburgh, Pennsylvania, United States
Baltimore, Maryland, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Boston, Massachusetts, United States
Hartford, Connecticut, United States
Morgantown, West Virginia, United States
Ottawa, Ontario, Canada
Washington, District Of Columbia, United States
Saint Louis, Missouri, United States
Durham, North Carolina, United States
Kansas City, Kansas, United States
Calgary, Alberta, Canada
Tampa, Florida, United States
London, Ontario, Canada
Atlanta, Georgia, United States
Wynnewood, Pennsylvania, United States
Newport Beach, California, United States
Tupelo, Mississippi, United States
London, Ontario, Canada
Hamilton, Ontario, Canada
Newark, Delaware, United States
Madrid, , Spain
Hollywood, Florida, United States
Dallas, Texas, United States
Roslyn, New York, United States
Omaha, Nebraska, United States
Lancaster, Pennsylvania, United States
Orlando, Florida, United States
Little Rock, Arkansas, United States
Charleston, South Carolina, United States
Toronto, Ontario, Canada
New Westminster, British Columbia, Canada
Louisville, Kentucky, United States
Vienna, , Austria
Barcelona, , Spain
Saint Louis, Missouri, United States
Fitzroy, Victoria, Australia
Columbus, Ohio, United States
Hamburg, , Germany
Columbus, Ohio, United States
Allentown, Pennsylvania, United States
Los Angeles, California, United States
Baton Rouge, Louisiana, United States
Saint John, New Brunswick, Canada
Boulder, Colorado, United States
Saint Louis, Missouri, United States
Southport, Queensland, Australia
Montréal, Quebec, Canada
Lexington, Kentucky, United States
Raleigh, North Carolina, United States
Milwaukee, Wisconsin, United States
Omaha, Nebraska, United States
Miami, Florida, United States
Wolverhampton, West Midlands, United Kingdom
Falls Church, Virginia, United States
Sioux Falls, South Dakota, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Seattle, Washington, United States
Nashville, Tennessee, United States
Little Rock, Arkansas, United States
Charlotte, North Carolina, United States
Hamburg, , Germany
Bad Neustadt An Der Saale, Bavaria, Germany
Jette, Brussels, Belgium
Carmel, Indiana, United States
Indianapolis, Indiana, United States
Des Moines, Iowa, United States
Little Rock, Arkansas, United States
Gainesville, Florida, United States
Tampa, Florida, United States
Louisville, Kentucky, United States
Pittsburgh, Pennsylvania, United States
Jackson, Tennessee, United States
Nashville, Tennessee, United States
Grand Rapids, Michigan, United States
Cincinnati, Ohio, United States
Huntsville, Alabama, United States
Ypsilanti, Michigan, United States
Toledo, Ohio, United States
Cambridge, , United Kingdom
Marietta, Georgia, United States
Kansas City, Missouri, United States
Atlantis, Florida, United States
Winston Salem, North Carolina, United States
Harrisburg, Pennsylvania, United States
Minneapolis, Minnesota, United States
Manhasset, New York, United States
Syracuse, New York, United States
Plano, Texas, United States
Tyler, Texas, United States
Norfolk, Virginia, United States
Middlesbrough, North Yorkshire, United Kingdom
Long Beach, California, United States
Kansas City, Kansas, United States
Jonesboro, Arkansas, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Scottsdale, Arizona, United States
Springfield, Illinois, United States
Austin, Texas, United States
Idaho Falls, Idaho, United States
Wausau, Wisconsin, United States
Québec, , Canada
Sheffield, Great Britain, United Kingdom
Sacramento, California, United States
Coon Rapids, Minnesota, United States
Orlando, Florida, United States
Dallas, Texas, United States
Royal Oak, Michigan, United States
Boston, Massachusetts, United States
Louisville, Kentucky, United States
New Brunswick, New Jersey, United States
Montréal, Quebec, Canada
Québec, , Canada
Brno, , Czechia
Leuven, Brabant, Belgium
Halifax, Nova Scotia, Canada
Bad Rothenfelde, Lower Saxony, Germany
Paramus, New Jersey, United States
Charleston, West Virginia, United States
Clayton, Victoria, Australia
Graz, Styria, Austria
Berlin, Brandenburg, Germany
Freiburg, , Germany
Hamilton, Waikato, New Zealand
London, Greater London, United Kingdom
Patients applied
Trial Officials
Richard Whitlock, MD
Study Chair
McMaster University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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