Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Running, not enrolling · Not applicable

Conditions studied: Ischemic Stroke, Systemic Embolism

In brief

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.

Key facts

Study ID

NCT05478304

Run by

AtriCure, Inc.

People needed

6573

Starts

2023-01-25

Expected to finish

2032-04-01

Last updated by the study team

2026-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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 D.C., 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
• 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
• Heart Center Research / Huntsville Hospital — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.