Study Type
Observational
completed
Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive procedure for high-risk patients with aortic stenosis that involves a high risk of developing cardiac arrhythmias and requires monitoring for 5-10 days post-surgery. Currently this monitoring is done using scares and expensive hospital telemetry beds.
A new mobile telemetry service (m-CARDS) will allow early discharge at 24 hours post-surgery, reducing pressure on hospital resources and improving patient experience.
Patients will receive pre- and post-TAVR monitoring via m-CARDS to examine the impact to cost-effectiveness, hospital readmissions, likelihood of hospital acquired infections and quality of life for patient and family.
Continuous home monitoring using the m-health solution is intended to detect intermittent conduction abnormalities, such as heart block and atrial fibrillation.
The primary objective of the Redirect TAVI study is to assess feasibility and patient and clinical team experience and to gather information useful for implementing a larger study for clinical outcomes including: length of stay post-TAVR; arrhythmia-related rehospitalizations; and cost-effectiveness.
Study Design
Prospective cohort
NO. of Countries
1
NO. of Sites
2
NO. of Participants
261
Study Period
2018-2021
Sponsor
PHRI
Madhu Natarajan
Investigator
Madhu Natarajan
Investigator
Madhu Natarajan is an interventional cardiologist and Principal Investigator for the Coronary Interventional Health Delivery and Knowledge Translational and Implementation programs at PHRI. He is a Professor at McMaster University, Director of Catheterization Laboratories at Hamilton Health Sciences, and Site Director for Cardiology at Hamilton General Hospital.
He has published more than 85 articles, is Chair of the STEMI-EMS Committee, Cardiac Care Network of Ontario, member of the Royal College Cardiology National Examination Board, and program lead for Regional STEMI network in LHIN-4 Ontario.
Jeff Healey
Senior Scientist
Jeff Healey
Senior Scientist
Jeff Healey is a Cardiologist/Electrophysiologist and Professor of Medicine at McMaster University. He is Yusuf Chair and Director of Cardiology at McMaster University. He is the chair of the Canadian Stroke Prevention and Intervention Network (CSPIN) and past chair of the Canadian Atrial Fibrillation guidelines committee. He is also on the steering committee of the international AF Screen organization.
Healey was the lead author of the ASSERT trial that demonstrated the increased stroke risk associated with sub-clinical atrial fibrillation (New England Journal of Medicine 2012), and the principal investigator of the ARTESIA trial, which demonstrated that anticoagulation with apixaban reduced the risk of stroke in patients with sub-clinical atrial fibrillation New England Journal of Medicine 2023). He is also the principal investigator of the LAAOS-4 trial, evaluating the role of left atrial appendage occlusion on top of NOAC therapy for prevention of stroke in high-risk individuals with atrial fibrillation.
Jessica Tyrwhitt
Program Manager
Jessica Tyrwhitt
Program Manager
Jessica Tyrwhitt has more than 10 years’ experience in coordinating and managing large, international clinical trials. She oversees interventional trials, registries, and observational research studies looking at primary and secondary prevention of cardiovascular disease in a variety of therapeutic areas, including cardiology, thrombosis, nephrology, cardio-oncology and diabetes.
She holds an Honours Bachelor of Science Degree & Business from the University of Waterloo.
