IMPACT (NCT04053088) | INDURE (NCT03666741) | RESILIENCE (NCT03680040) | |
---|---|---|---|
Valve used | INSPIRIS valves | INSPIRIS valves | RESILIA tissue valves |
Design | Prospective | Prospective | Retrospective inclusion, prospective follow-up |
Study Start date | 12 December 2019 | 26 April 2019 | 5 November 2018 |
Baseline | Implantation | Implantation | 5 years |
Follow-up | 5 years – projected completion 2026 | 5 years – projected completion 2025 | 6 years (from year 5 to year 11) – projected completion 2027 |
Subjects/centers | 500 subjects, ~ 25 centers (Austria, Germany, The Netherlands and Switzerland), patients ≥18 years at the time of their SAVR | 400 subjects, 20–25 centers (EU and Canada), patients ≤60 years at the time of their SAVR | 220 subjects, up to 15 centers (US and EU), patients ≤65 years at the time of their SAVR |
Objective | Assess clinical outcomes in patients with pre-existing comorbidities | Assess clinical outcomes | Time to valve failure due to valve degeneration requiring re-intervention & early potential predictors of valve durability |
Primary endpoints | All-cause mortality at 1, 3 and 5 years after SAVR | 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 [27] |
Rate of severe SVD (stage 3 following Salaun [19]) at 5 years (Echo CoreLab) | |||
Secondary endpoints | Mortality (all-cause, cardiac-related and valve-related) in overall population and patient subgroups Hemodynamics and durability Clinical outcomes (NYHA; freedom from rehospitalization, new pacemaker implant and valve-related complications) | Hemodynamics and durability (Echo CoreLab) Clinical outcomes (NYHA and freedom from rehospitalization) Quality-of-life (KCCQ & SF-12) | Early possible predictors of valve failure including leaflet calcification and morphological/hemodynamic valve degeneration: - Valve leaflet calcification via CoreLab evaluated MSCT (no contrast) - Hemodynamic performance (Echo CoreLab) |