Interventional - Drug
Atrial fibrillation is a common heart condition that happens when the top two chambers of the heart, the atria, beat too fast and with an irregular rhythm (fibrillation). This condition can decrease the heart’s pumping capacity, which can cause blood cells to pool and stick together, forming clots in a small pouch on the heart called the left atrial appendage. If a clot escapes from the appendage and gets into your arteries, it may block the blood supply to your brain and cause a stroke. Atrial fibrillation is associated with a 3-5 times increased risk of stroke.
The purpose of the LAAOS-4 study is to determine if closure of the left atrial appendage using a closure device called the WATCHMAN FLX™, in addition to taking oral anticoagulant medications, is more effective at reducing strokes and blood clots in your body, than taking oral anticoagulant medications on their own.
The primary efficacy outcome of LAAOS-4 is ischemic stroke or systemic embolism. Secondary efficacy outcomes include all-cause stroke, systemic embolism or transient ischemic attack, change in MoCA score between visits, new disabling ischemic stroke with mRS >2 measured at 90 days post-stroke, CV mortality and all-cause mortality.
The LAAOS-4 study will enroll participants from North America and Europe. After enrollment, a patient will be randomized to either the intervention arm (receive the WATCHMAN FLX™ device) or the control arm (stay on oral anticoagulants). Follow-up visits will occur at 6-month intervals until the end of the study.
Interventional - Drug
Multicentre, prospective, open-label, randomized controlled trial with blinded assessment of endpoints (PROBE)
2023 - 2029
Jeff Healey is a Senior Scientist in the Arrhythmia and Heart Failure research program at PHRI, an Associate Professor, Medicine, McMaster University, and Director of Arrhythmia Services at Hamilton Health Sciences. His research involves conducting RCTs and large registries in the fields of atrial fibrillation and cardiac devices. He was the lead author of the SIMPLE trial, published in the Lancet in 2015, which demonstrated that implantable defibrillators could be safely inserted without performing intra-operative defibrillation testing.
He was the lead author of the ASSERT trial, published in New England Journal of Medicine in 2012, demonstrating the increased stroke risk associated with sub-clinical atrial fibrillation detected by pacemakers. Thomson-Reuters recognized ASSERT as the 38th most-cited scientific publication in 2012 (#16 in Medicine).
He was principal investigator and chair of the Canadian Stroke Prevention Intervention Network (CSPIN), a ten-year network grant funded by the Canadian Institutes of Health Research, The Heart and Stroke Foundation of Canada and Industry. He is the past co-chair of the Canadian Cardiovascular Society’s Atrial Fibrillation Guidelines Committee. Jeff has published more than 185 manuscripts.
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.
Sanjit Jolly is an interventional cardiologist at Hamilton Health Sciences and associate professor at McMaster University. He has formal training in clinical trials with a M.Sc. in Health Research Methodology from McMaster. He was the principal investigator of the RIVAL trial, a randomized trial of 7021 patients comparing radial and femoral access for coronary intervention. He is also the principal investigator trial of the ongoing TOTAL trial, an international randomized trial (N=10,700) of thrombectomy during primary PCI.
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
Alex Grinvalds has more than 15 years experience in clinical research, of which 13 have been at PHRI. He has worked on randomized studies, device trials and numerous registries. Currently, Alex is working on studies involving patients with heart failure and arrhythmias.
Alex holds a Bachelor of Science degree from Queen’s University and a Certificate in Clinical Research from Humber College.
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