PRospective Evaluation Complementing Investigation With Acurate Neo Device (PRECISA)

Proportion of patients with device success of implantation defined as:

• absence of procedural mortality AND
• correct positioning of a single prosthetic heart valve into the proper anatomical location AND
• no prosthesis - patient mismatch AND
• mean aortic valve gradient <20 mmHg, AND
• no moderate or severe prosthetic valve regurgitation

Proportion of patients with early safety defined by the Valve Academic Research Consortium-2 (VARC-2) as:

• All-cause mortality
• All stroke (disabling and non-disabling)
• Life-threatening bleeding
• Acute kidney injury-Stage 2 or 3 (including renal replacement therapy)
• Coronary artery obstruction requiring intervention
• Major vascular complication
• Valve-related dysfunction requiring repeat procedure

Proportion of patients with structural valve deterioration as defined by:

• Requiring repeat procedure (transcatheter or surgical heart valve replacement)

• Valve-related dysfunction defined by

  • mean aortic valve gradient ≥20 mmHg and
  • no moderate or severe prosthetic valve regurgitation
• Prosthetic valve endocarditis
• Prosthetic valve thrombosis
• Thrombo-embolic events (e.g. stroke)
• VARC bleeding, unless clearly unrelated to valve therapy