Ross for Valve replacement In AduLts (REVIVAL) pilot trial: rationale and design of a randomised controlled trial.

ABSTRACT:

Introduction

In non-elderly adults, aortic valve replacement (AVR) with conventional prostheses yield poor long-term outcomes. Recent publications suggest a benefit of the Ross procedure over conventional AVR and highlight the need for high-quality randomised controlled trial (RCTs) on the optimal AVR. We have initiated a pilot trial assess two feasibility criteria and one assumption: (1) evaluate the capacity to enrol six patients per centre per year in at least five international centre, (2) validate greater than 90% compliance with allocation and (3) to validate the proportion of mechanical (≥65%) vs biological (≤35%) valves in the conventional arm.

Methods and analysis

Ross for Valve replacement In AduLts (REVIVAL) is a multinational, expertise-based RCT in adults aged 1

SUBMITTER: Whitlock R 

PROVIDER: S-EPMC8449981 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature