INDURE (NCT03666741) | RESILIENCE (NCT03680040) | |
---|---|---|
Valve used | INSPIRIS valves | RESILIA tissue valves |
Design | Prospective | Retrospective inclusion, prospective follow-up |
Study Start date | 26 April 2019 | 5 November 2018 |
Baseline | Implantation | 5 years |
Follow-up | 5 years – projected completion 2025 | 6 years (from year 5 to year 11) – projected completion 2027 |
Subjects/centres | 400 subjects, 20–25 centres (EU and Canada) under the age of 60 years at the time of their SAVR | 220 subjects, up to 15 centres (US and EU) under the age of 65 years at the time of their SAVR |
Objective | Assess clinical outcomes | Time to valve failure due to valve degeneration requiring re-intervention & early potential predictors of valve durability |
Primary endpoints | Time-related valve safety at 1 year (VARC-2) | Time to BVF due to SVD, defined as requiring re-intervention (redo surgery or ViV), or confirmed valve related death, according to Akin criteria [29] |
Rate of severe SVD (stage 3 following Salaun [24]) at 5 years (Echo CoreLab) | ||
Secondary endpoints | Haemodynamics and durability (Echo CoreLab) Clinical outcomes (NYHA and freedom from rehospitalisation) Quality-of-life (KCCQ & SF-12) | Early possible predictors of valve failure including leaflet calcification and morphological/haemodynamic valve degeneration: -Valve leaflet calcification via CoreLab evaluated MSCT (no contrast) -Haemodynamic performance (Echo CoreLab) |