'Off pump' self-expanding injectable tissue valves (IPVR) versus 'on pump' conventional tissue valves (PVR) for replacement of the pulmonary valve: trial protocol for a randomised controlled trial (InVITe trial).

ABSTRACT:

Introduction

Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve. Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB).

Methods and analysis

We are conducting a multicentre, single-blind randomised controlled trial in patients with congenital heart disease and aged between 12 and 80 years. We will randomise participants in a 1:1 ratio to receive either 'off pump' injectable pulmonary valve replacement or 'on pump' conventional pulmonary valve replacement. The prim

SUBMITTER: Heys R 

PROVIDER: S-EPMC6500208 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature