Table 11

Composite Endpoints

Device Success
  •  • Successful vascular access, delivery and deployment of the device and successful retrieval of the delivery system

  •  • Correct position of the device in the proper anatomical location

  •  • Intended performance of the prosthetic heart valve (aortic valve area 1.2 cm2 and mean aortic valve gradient, 20 mm Hg or peak velocity, 3 m/s, without moderate or severe prosthetic valve AR)

  •  • Only 1 valve implanted in the proper anatomical location

Combined Safety Endpoint (at 30 Days)
  •  • All-cause mortality

  •  • Major stroke

  •  • Life-threatening (or disabling) bleeding

  •  • Acute kidney injury—Stage 3 (including renal replacement therapy)

  •  • Periprocedural MI

  •  • Major vascular complication

  •  • Repeat procedure for valve-related dysfunction (surgical or interventional therapy)

Combined Efficacy Endpoint (at 1 Year or Longer)
  •  • All-cause mortality (after 30 days)

  •  • Failure of current therapy for AS, requiring hospitalization for symptoms of valve-related or cardiac decompensation

  •  • Prosthetic heart valve dysfunction (aortic valve area 1.2 cm2 and mean aortic valve gradient ≥20 mm Hg or peak velocity ≥3 m/s, OR moderate or severe prosthetic valve AR)

Reprinted with permission from Leon et al (96).

AR indicates aortic regurgitation; and AS, aortic stenosis.