TORONTO, ON--(Marketwired - April 12, 2017) - During a live broadcast on Wednesday, April 26, 2017, a panel of experts will discuss and examine embolic protection devices and the potential impact these may have on TAVR patients.
The speakers include:
- Alan B. Lumsden, MD, ChB, RVT, FACS, Medical Director, Medical Metrics and Medical Director, Methodist DeBakey Heart & Vascular Center, Professor and Chairman, Department of Cardiovascular Surgery, Houston Methodist Hospital
- Zsolt Garami, MD, Director of Vascular Imaging, Medical Metrics, Medical Director, Vascular Ultrasound Laboratory, Houston Methodist Hospital and Assistant Professor of Radiology in Cardiovascular Surgery, Houston Methodist Hospital
- Richelle Massey, Senior Director, Project Management, Medical Device & Diagnostic Division, Novella Clinical
Transcatheter aortic valve replacement (TAVR) or implantation (TAVI) demonstrably changed the treatment of high-risk patients with severe aortic stenosis, particularly those at high risk for surgical replacement of the aortic valve. However, greater acceptance of TAVR also raised concerns of complications, particularly increased risks for stroke or neurological and cognitive impairments from embolic events. The entry of embolic protection devices (EPD) into the European market, with designs that deflect or collect potentially damaging micro-debris associated with TAVR, presents an evolving risk-reduction safety strategy to manage patients with frail health or existing comorbidities.
This webinar explores the potential for EPDs as well as factors Novella Clinical and Medical Metrics believe sponsors should consider when developing or using EPDs in clinical trials.
- Cerebral embolic protection and current State of the Art
- Device performance and outcomes
- Role of imaging in study outcome assessment
- Considerations for clinical trial design
- Gain an understanding of the latest research and clinical outcomes of ongoing EPD studies
- Learn the new definition of stroke and silent stroke
- Understand appropriate use of DW-MRI and what parameters to assess
- Learn how to select measurable endpoints to address efficacy and safety
- Recognize the most efficient regulatory pathway to approval
- Understand critical trial design considerations, including site selection, training, patient enrollment and pre-screening
To learn more about this complimentary event visit: Clinical Trial Considerations in Cerebral Protection for TAVR Patients -- An Examination of Study Design, Endpoints and Imaging Methods
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