Table 1 Registry objectives

Primary objectives

Time-related valve safety at 1 year (composite endpoint according to VARC-2 [23] depicted as freedom from the following events:

 • SVD (valve-related dysfunction [MPG ≥20 mmHg, EOA ≤0.9–1.1 cm² and/or DVI < 0.35 m/s, AND/OR moderate or severe prosthetic valve regurgitation], requiring repeat procedure [TAVI or SAVR])

 • Valve-related dysfunction

 • Requirement of repeat procedures (Re-intervention)

 • Prosthetic valve endocarditis

 • Prosthetic valve thrombosis

 • Thromboembolic events (e.g., stroke)

 • Valve-related VARC bleeding

To determine freedom from stage 3 SVD following [24] at 5 years

Secondary objectives

Haemodynamics and durability:

 • Haemodynamic performance of the INSPIRIS RESILIA Aortic Valve™ including PPM

 • SVD following Salaun [24]

 • Description of potential ViV procedures and clinical outcome including follow-up

Clinical outcomes:

 • NYHA functional class compared to baseline

 • Freedom from valve-related rehospitalisation

Quality-of-life:

 • 3–6-month, 1-year and 3-year change from baseline in quality-of-life assessed by the KCCQ and SF-12 Health Survey

Exploratory: Rehospitalisation and costs

Length of hospital stay

Length of time in intensive care unit

Time to return to work

Rate of valve-related rehospitalisation and associated costs (average costs per country)

Rate of transfusion for bleeding and associated costs (average costs per country)

Costs of a major bleeding event

Costs of daily anticoagulation

Rate of re-intervention for valve degeneration and associated costs (average costs per country)

Exploratory: Safety

SVD

Non-SVD

Thromboembolic events (e.g., stroke)

Valve thrombosis

All bleeding/haemorrhage

Major bleeding/haemorrhage

All paravalvular leak

Major paravalvular leak

Endocarditis

All-cause mortality

Cardiac-related mortality

Valve-related mortality

Valve-related re-intervention

Conduction disturbances

Myocardial infarction

Deep sternal wound infection

Acute kidney injury