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Table 4 INDURE vs. RESILIENCE

From: Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry

 

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)

  1. BVF Bioprosthetic valve failure, EU European Union, KCCQ Kansas City Cardiomyopathy Questionnaire, MSCT Multi-slice computed tomography, NYHA New York Heart Association, SF-12 Short Form-12, SVD Structural valve degeneration, US United States, VARC Valve Academic Research Consortium, ViV Valve-in-valve