Table 2 Study endpoints

Primary efficacy endpoint

 Device success rate (at 30 days) according to VARC-3 criteria

 Technical success (at exit from procedure room)

  Freedom from mortality

  Successful access, delivery of the device, and retrieval of the delivery system

  Correct positioning of a single prosthetic heart valve into the proper anatomical location

  Freedom from surgery or intervention related to the device* or to a major

  Vascular or access-related, or cardiac structural complication

 Freedom from mortality

 Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication

 Intended performance of the valve‡ (mean gradient < 20 mmHg, peak velocity < 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation)

Secondary efficacy endpoints

  Technical success rate

  The rate of patients with AR ≤ 2 + after surgery (7 days after procedure/before discharge, 30 days, 6 months and 12 months)

  The rate of postoperative hospitalization for heart failure (7 days after procedure/before discharge, 30 days, 6 months and 12 months)

  The rate of NYHA class I or II after procedure (7 days after procedure/before discharge, 30 days, 6 months and 12 months)

  Improvement of 6MWD from baseline (baseline and 12 months after procedure)

  BNP/NT-proBNP improvement from baseline (baseline and 12 months after procedure)

  Changes of echocardiographic LVEDV from baseline (baseline and 12 months after procedure)

  Improvement of quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score (baseline and 12 months)

Safety endpoints

  Incidence of MACCEs during the study

  Defined as the composite endpoints of death, stroke, myocardial infarction, renal failure, arrhythmia, and conduction block occurring after the puncture approach, and reoperation for device- or surgery-related adverse events

  All-cause mortality (30 days, 6 and 12 months after procedure)

  All-cause deaths include cardiac deaths, non-cardiac deaths, and unexplained deaths

  Cardiac mortality (30 days, 6 and 12 months after procedure)

  Post-procedure rehospitalization rate due to heart failure (30 days, 6 and 12 months after procedure)