Safety, effectiveness and haemodynamic performance of a new stented aortic valve bioprosthesis.

ABSTRACT:

Objectives

We assessed the safety, effectiveness and haemodynamic performance of a new bovine stented aortic valve bioprosthesis (Avalus™).

Methods

The PERIGON Pivotal Trial is a prospective, non-randomized, multicentre study. Subjects had symptomatic moderate or severe aortic stenosis or chronic, severe aortic regurgitation. Death, valve-related adverse events (AEs), functional recovery and haemodynamic performance were assessed at discharge, 3-6 months and 1 year. The primary analysis compared 'late' (>30 days post-implant) linearized rates of valve-related thromboembolism, thrombosis, all and major haemorrhage, all and major paravalvular leak (PVL) and endocarditis after implantation with objective performance criteria (OPC) for AEs, in accordance with EN ISO 5840:2009. W

SUBMITTER: Klautz RJM 

PROVIDER: S-EPMC5848807 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature