SARASOTA (May 9, 2024) – Sarasota Memorial is one of up to 250 research sites participating in a multi-center, multi-national clinical trial to determine whether sealing a small, seemingly unnecessary sac in the heart during routine cardiac surgery can prevent strokes in some patients.
Cardiac specialists have been closing the finger-like pouch called the left atrial appendage (LAA) for years to reduce the risk of stroke in patients with atrial fibrillation (Afib). Devices such as the FDA-cleared AtriClip and LAA closure devices have demonstrated to be simple, effective, and low risk additions to routine cardiac procedures for patients with Afib.
The U.S. Food and Drug Administration approved the ‘Left Atrial Appendage Exclusion for Prophylactic Stroke Prevention (LeAAPS)’ trial to determine if implanting the AtriCure AtriClip® LAA exclusion system offers protection against ischemic stroke or systemic embolism in patients who do not have Afib, but are at risk for developing Afib.
Patients who are scheduled for routine heart surgery, such as artery bypass or valve replacement procedures, and have one or more risk factors for developing Afib (which puts them at greater risk for stroke) will be screened for the study, said Jeffrey Sell, MD, Chief of Cardiac Surgery, FPG cardiovascular surgeon and principal investigator of the study at SMH.
“We know that AtriClip and other closure devices have been safe and effective at preventing strokes in patients with Afib,” Dr Sell said.
“We hope this trial will show that implanting AtriClip also can reduce the risk of stroke in people who do not have Afib, but who are at higher risk of developing Afib and suffering a stroke.”
The LAA is a small sac on the left atrium of the heart that fills with blood and empties with every beat of the heart. In most people, the LAA is of little or no concern. However, in some people with certain heart conditions, especially Afib, blood can pool in the pouch and form blood clots that can break free and cause a stroke or other embolic complication. Afib is an abnormal heart rhythm that affects about one in 10 people by age 70 and the risk gradually increases with age.
LeAAPS is a prospective, randomized, blinded, superiority study that will enroll up to 6,500 subjects. Patients who already have Afib are excluded from the study. Patients will be divided into two groups: one is a treatment group in which surgeons will implant the AtriClip in conjunction with another cardiac surgical procedure; the second is a control group in which patients undergo a scheduled cardiac procedure but do not receive the AtriClip. Researchers will be monitoring both groups of patients for stroke, systemic embolization, Afib, and other risk factors for at least five years.
More information about the trial is available on clinicaltrials.gov (Identifier: NCT05478304) or by calling the Sarasota Memorial Research Institute at (941) 917-2225.
