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Search / Trial NCT05478304

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Launched by ATRICURE, INC. · Jul 26, 2022

Trial Information

Current as of July 24, 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.

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

0 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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