MedDRA - 10002918 (Aortic valve stenosis) MedDRA - 10050559 (Aortic valve calcification) I35.0
Conditions
Interventions
Group 1: All Patients undergoing transaortic transcatheter valve implantation with commercially available Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System.
Sponsors
IPPMed GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Intended transaortic (Tao) TAVI using Edwards SAPIEN XT Transcatheter Heart Valve with the Ascendra+ Delivery-System - Compliance with the indications according to the Instructions for Use (Appendix 12.1) - Written informed consent
Exclusion criteria
Exclusion criteria: - Presence of contraindications as to the Instructions for Use - TAo with concomitant procedure (e.g. Tao + CABG) - Participation in the SOURCE XT registry Data collection and follow-up Patient data are collected at valve implantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall mortality within 30d after TAVI. | — |
Secondary
| Measure | Time frame |
|---|---|
| - TAVI related in-hospital and 30d mortality - Complication rates as to VARC2 (Valve Academic Research Consortium-2) - Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI - Further establish role of CT-technology in patient screening (valve sizing, complication prevention) | — |
Countries
Austria, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, United Kingdom
Contacts
Public ContactKerstin Plate
IPPMed GmbH
Outcome results
None listed