Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

ABSTRACT:

Background

Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction.

Aims

The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients.

Methods

Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volum

SUBMITTER: Jagielak D 

PROVIDER: S-EPMC10241272 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature