Aortic stenosis Aorticvalve stenosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subject is * 18 years of age. 2. Subject is eligible for TAVI with a a CE approved transcatheter heart valve. 3. Subject understands the study requirements and the treatment procedures, and provides written informed consent. 4. Subject is capable of returning to the study hospital for all required follow-up.
Exclusion criteria
Exclusion criteria: 1. The aortic root cannot be defined by the software. 2. Subject did not receive a valve because of aborted procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Volume of contrast. - Valve deployment time. - Depth of implantation of the valve (non-coronary and left aortic sinus) in mm based upon contrast angiography after valve deployment. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Mortality within the hospital or at 30 days whichever comes first. - Renal insufficiency. - Paravalvular aortic regurgitation. | — |
Countries
Netherlands