An examination of study design, considerations and endpoints
Transcatheter aortic valve replacement (TAVR) changed the treatment of high-risk patients with severe aortic stenosis, while also raising concerns of complications, such as increased risk for stroke. The entry of embolic protection devices (EPD) that deflect or collect potentially damaging micro-debris associated with TAVR, presents an evolving risk-reduction safety strategy for patients. This paper explores the potential for cerebral protection devices and factors we believe sponsors should consider when developing or using EPDs in clinical trials.
- Understand the latest research and clinical outcomes of ongoing EPD studies
- Recognize appropriate use of DW-MRI and what parameters to assess
- Learn how to select measureable endpoints to address efficacy and safety
- Review critical trial design considerations, including site selection, training, patient enrollment and pre-screening