Study Type
Interventional - Device
ongoing
The purpose of the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) trial is to test if closing off the small sac attached to the heart called the left atrial appendage (LAA) with a surgical device known as the AtriClip reduces stroke occurrence. LeAAPS includes patients who do not have atrial fibrillation (AF) but who have one or more risk factors for developing AF in the next 5 years. To properly answer this question, patients who are scheduled for heart surgery, such as artery bypass or valve replacement surgery, and have one or more risk factors for developing AF will be screened. Patients who meet all the trial requirements and agree to participate will be enrolled.
AF is an abnormal heart rhythm that is quite common, especially as people age. It can be detected in 10% of those over the age of 70. AF is uncommon below age 50 and then increases gradually with age so that, by age 70, about 10% of people have had AF. The risk continues to increase beyond age 70 so that by age 80, about 15% of people have AF. Some patients with AF have some symptoms of heart racing, others take medication to control their heart rhythm and others have no symptoms at all. Patients with AF are more likely to have a stroke compared to patients who do not have AF. In patients with AF, there is a tendency for a blood clot to form in the LAA. Such a blood clot can dislodge and travel to the brain where it closes an artery. This can cause a stroke due to a sudden decrease in blood supply to the brain.
For patients with AF, it has now been shown that excluding or closing off the LAA reduces the risk of stroke. This is now done in many hospitals when surgery is performed in patients who also have AF. Excluding or closing off the LAA takes only a few minutes and has a low risk of complications.
It is not known whether excluding or closing off the LAA at the time of surgery for other reasons is beneficial in patients who do not have AF. However, there are many patients who do not have AF, but have one or more risk factors for developing AF. The main risk factors for developing AF are increasing age and other elements of the CHA2DS2-VASc score (a clinical score to determine your risk for stroke). In patients who have risk factors for AF and are having surgery, it may be beneficial to exclude or close off the LAA because if they develop AF in the future, they could be protected from a stroke due to a blood clot. The LeAAPS trial will be testing the safety and effectiveness of using the AtriClip surgical device for the reduction of stroke occurrence.
Study Design
Multicentered, blinded RCT
NO. of Countries
10
NO. of Sites
150
NO. of Participants
6500
Study Period
2023-2032
Sponsor
AtriCure, Inc.
Richard Whitlock
Scientist
Richard Whitlock
Scientist
Richard Whitlock is Associate Chair, Research, and a Professor at the Department of Surgery, McMaster University. He was awarded the inaugural Canada Research Chair in Cardiovascular Surgery in 2020.
As well as being a PHRI Scientist, Richard is a cardiac surgeon and intensive care physician at Hamilton Health Sciences. His clinical focus is on aortic valve intervention and aortic surgery. He is a lead investigator for the CIHR funded studies SIRS, LAAOS III, and TRICS III, which have established a network of more than 120 centres to address important questions in his field.
He has published more than 90 articles in referred journals. Medically qualified at the University of Toronto, Richard received his specialist training in cardiac surgery and critical care medicine at McMaster University. In 2012, he received his PhD in clinical epidemiology.
Stuart Connolly
Stuart Connolly
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
Jessica Vincent
Program Director
Jessica Vincent
Program Director
Jessica Vincent has more than 15 years’ experience in coordinating and managing large, international clinical trials. As Associate Program Manager, she oversees interventional trials, registries, and observational research studies in the areas of perioperative medicine, cardiac surgery, and digital health.
She holds an Honours Bachelor of Science Degree from Queens University, and a Master of Clinical Epidemiology Degree from the University of Newcastle.
ongoing
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