| 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 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) |
| Only one 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) |
| Peri-procedural 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 mmHg or peak velocity ≥3 m/s, OR moderate or severe prosthetic valve AR) |
| 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 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) |
| Only one 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) |
| Peri-procedural 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 mmHg or peak velocity ≥3 m/s, OR moderate or severe prosthetic valve AR) |
| 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 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) |
| Only one 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) |
| Peri-procedural 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 mmHg or peak velocity ≥3 m/s, OR moderate or severe prosthetic valve AR) |
| 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 mmHg or peak velocity <3 m/s, without moderate or severe prosthetic valve AR) |
| Only one 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) |
| Peri-procedural 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 mmHg or peak velocity ≥3 m/s, OR moderate or severe prosthetic valve AR) |
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