ROUTE registry

Recruiting

• Conditions: I35.0; MedDRA - 10002918 (Aortic valve stenosis)MedDRA - 10050559 (Aortic valve calcification); Aortic (valve) stenosis

• Registration Number: DRKS00005294
• Lead Sponsor: IPPMed GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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

- 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

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall mortality within 30d after TAVI.

Secondary Outcome Measures

Name	Time	Method
- TAVI related in-hospital and 30d mortality<br>- Complication rates as to VARC2 (Valve Academic Research Consortium-2)<br>- Identify multivariable adjusted predictors for adverse outcomes of transaortic TAVI<br>- Further establish role of CT-technology in patient screening (valve sizing, complication prevention)