Clinical Trial Considerations in Cerebral Protection for TAVR Patients
White Paper
Jan 08, 2020
Embolic protection devices and their potential impact on TAVR patients

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 (EU) market, with designs that deflect or collect potentially damaging micro-debris associated with TAVR, presents an evolving risk-reduction safety strategy to manage patients, who usually are elderly, with frail health or existing comorbidities.

This paper explores the potential for such EPDs as well as factors IQVIA MedTech believes sponsors should consider when developing or using EPDs in clinical trials.

Contact Us
Contact Us

Email Us

Get in touch today to discover the right solutions for you.

Call Us

We are pleased to speak with you during our standard business hours.

U.S. Toll-Free only
+1 866 267 4479

For international call please find a number in our toll-free list.