Skip to main content

Table 3 IMPACT vs. INDURE vs. RESILIENCE

From: Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement – rationale and design of the international IMPACT registry

 

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)

  1. Legend: 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