Study Type
Surgical
ongoing
SAFE is an international multicentre randomized controlled trial of concomitant surgical atrial fibrillation (AF) ablation in 2000 patients with paroxysmal or persistent AF undergoing cardiac surgery. The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation.
Primary outcome: Hospital readmissions for heart failure during 4 years of follow-up.
Secondary outcomes – over the duration of follow-up (unless otherwise specified):
- Ischemic stroke or systemic arterial embolism
- Length of ICU and hospital stay
- Freedom from recurrence of atrial tachycardia
- Number of days free from admission to healthcare facility for heart failure or presentation to the emergency department for heart failure
- Mortality
- Cardiovascular mortality
- Antiarrhythmic drug use beyond 6 weeks
- AF ablation after 90 days
- Quality of life: AF-specific as assessed by the validated Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT); general as assessed by the European quality of life index version 5D (EQ-5D) (for health utilities); and a patient-centric HF questionnaire, the Kansas City Cardiomyopathy Questionnaire (KCCQ) at baseline and annually over the duration of follow-up.
Study Design
Randomized controlled trial
NO. of Countries
12
NO. of Sites
50
NO. of Participants
2000
Study Period
2022 - 2026
Sponsor
PHRI
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.
Emilie Belley-Côté
Scientist
Emilie Belley-Côté
Scientist
Emilie Belley-Côté is an Assistant Professor in the Department of Medicine at McMaster University; she practices critical care cardiology in the cardiovascular intensive care unit and coronary care unit at the Hamilton General Hospital. Her research interests include perioperative cardiac surgery care, knowledge synthesis and guideline development. At this stage in her career, she has more than 120 publications, including articles in NEJM, Lancet, JAMA, as well as first-tier critical care journals.
She obtained her MD from Université de Sherbrooke in 2006. After internal medicine and cardiology training, as well as an MSc in Clinical Sciences, she completed a critical care fellowship at McMaster. In 2019, she completed a PhD in Health Research Methodology at McMaster 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.
Kate Brady
Project Manager
Kate Brady
Project Manager
Kate Brady has worked in clinical research since 2008 and joined PHRI in 2010. She has experience in coordinating large international clinical trials and observational studies with a focus on cardiac surgery. She has an Honour’s Bachelor Degree in Science with an Honours Specialization in Genetics from Western University and a post-graduate certificate in Clinical Research from Humber College.
