First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement.

ABSTRACT:

Background

Stroke and other clinically significant embolic complications are well documented in the early period following transcatheter aortic valve replacement (TAVR). The CAPTIS device is an embolic protection system, designed to provide neurovascular and systemic protection by deflecting debris away from the brain's circulation, capturing the debris and thus avoiding systemic embolisation.

Aims

We aimed to study the safety and feasibility study of the CAPTIS complete cerebral and full-body embolic protection system during TAVR.

Methods

A first-in-human study investigated the safety, feasibility and debris capturing ability of CAPTIS during TAVR. Patients were followed for 30 days. The primary endpoints were device safety and cerebrovascular events at 72 hours.

SUBMITTER: Danenberg H 

PROVIDER: S-EPMC10719740 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature