Cardiac centers around the world are accepting patients for a clinical trial for patients undergoing cardiac surgery that may have risk factors for atrial fibrillation (A-fib) and ischemic stroke.

Norton Heart & Vascular Institute will be one of four facilities in Kentucky enrolling for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) clinical trial, which aims to evaluate the effectiveness of left atrial appendage exclusion (LAAE) in preventing ischemic stroke and arterial embolism in cardiac surgery patients. More than 87% of strokes are ischemic, and the American College of Cardiology estimates that acute ischemic stroke associated with A-fib may account for up to 30%.

This trial is studying treatment using the AtriClip LAA Exclusion System. In its current use, a cardiac surgeon uses an AtriClip to permanently seal the left atrial appendage at the base. Closing off this pouchlike structure in the heart decreases the risk of stroke in A-fib patients, as blood clots are less likely to form in this area.

The trial seeks to evaluate the effectiveness of LAAE for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who may also have risk factors for atrial fibrillation and ischemic stroke.

A publication in the Journal of American Heart Association cites that perioperative stroke after cardiac surgery is a known complication, and the incidence rate has ranged from 0.8% to 5.2% despite advances in surgical techniques. According to the publication, postoperative stroke is largely attributed to A-fib, the most common arrhythmia to occur following cardiac surgery.

The Food and Drug Administration approved the AtriClip system in 2009, and it is currently the most widely used LAAE device implanted via epicardial approach. Small studies have shown significant reliability and success of complete closure with the AtriClip device. This clinical trial hopes to illustrate the stroke prevention potential of this device in patients who are at risk for A-fib.

“The cardiac surgery team at Norton Heart & Vascular Institute has been utilizing AtriClip since 2012. We complete more than 1,100 cardiac surgery procedures each year. Our experience with this device paired with the number of surgical procedure candidates we serve, positions us to be an optimal site to contribute to this trial while potentially giving early access to this treatment option for a patient that qualifies for the study,” Dr. Graham said.

Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction Trial (LeAAPS) study guidelines

The LeAAPS study, listed at ClinicalTrials.gov as NCT05478304 is a prospective, randomized, multicenter, multinational, blinded, superiority trial.

This study, sponsored by AtriCure Inc., currently has 115 total sites globally and hopes to enroll 6,500 total, with at least 50% enrolled in the U.S.

Participation criteria include:

• Subjects age 18 or older

• Documentation of any of the following clinical criteria, based on CHA₂DS₂-VASc Score for Atrial Fibrillation Stroke Risk

• • 4 or greater with age 65 or older
  • 4 or greater with significant left atrium enlargement or elevated N-terminal pro-brain natriuretic peptide (NT-proBNP)
  • 3 with age 75 or older
  • 3 with significant left atrium enlargement or elevated NT-proBNP
  • 2 with age 65 or older and significant left atrium enlargement or elevated NT-proBNP

Exclusion criteria include (and are not limited to):

• Clinically significant atrial fibrillation or atrial flutter:

• • Anytime in the past and
  • Documented by an electrocardiographic recording and
  • Episode lasting six minutes or longer
• Prior procedure involving opening the pericardium or entering the pericardial space
• Prior left atrial appendage occlusion, exclusion or removal (surgical or percutaneous)
• Planned cardiac surgical procedure using nonsternotomy approaches (partial sternotomies allowed)
• Patients whose planned procedure is a heart transplant or implantation of any ventricular assist devices