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Preventing strokes during heart surgery by excluding the left atrial appendage

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial

Not applicable Interventional AtriCure, Inc. · NCT05478304

This study is testing if a procedure to close off a part of the heart can help prevent strokes in patients at risk for atrial fibrillation during heart surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment6500 (estimated)
Ages18 Years and up
SexAll
SponsorAtriCure, Inc. Industry-sponsored
Locations127 sites (Huntsville, Alabama and 126 other locations)
Trial IDNCT05478304 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness of left atrial appendage exclusion (LAAE) in preventing ischemic stroke and systemic embolism in patients undergoing cardiac surgery who are at risk for atrial fibrillation. It is a prospective, randomized, multicenter, multinational, blinded, superiority trial. Participants will be randomly assigned to receive the AtriClip LAA Exclusion System or standard care. The study aims to determine if LAAE significantly reduces the incidence of strokes in this high-risk population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific risk factors for atrial fibrillation and ischemic stroke, as indicated by their CHA2DS2-VASc scores.

Not a fit: Patients with a history of clinically significant atrial fibrillation or those who have undergone prior procedures involving the pericardium may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of stroke in patients undergoing cardiac surgery.

How similar studies have performed: Other studies have shown promise in similar approaches, but this specific trial is designed to provide further evidence on the effectiveness of LAAE in this context.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Huntsville, Alabama and 126 other locations

+77 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ischemic StrokeSystemic Embolism
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.