Evolut PRO+ System (chronic dialysis patients) Use-Results Surveillance

Not Applicable

• Conditions: aortic stenosis

• Registration Number: JPRN-jRCT2052230032
• Lead Sponsor: Tajima Ai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-07
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

In the surveillance, chronic dialysis patients who are used the product at the surveillance sites (PRO+model: 23 mm, 26 mm, 29 mm, 34 mm, FX model: 23 mm, 26 mm, 29 mm, 34 mm) are subjects to be surveyed.

This product is a self-expanding percutaneous aortic valve system (porcine pericardium tissue valve) which used for the percutaneous heart valve replacement and indicated for the following patients.
- Patients with severe symptomatic native aortic stenosis caused by the calcification of native aortic valve leaflets and whom are determined that the therapy using this product is the most suitable treatment. However, in the case of chronic dialysis patients, it is limited to those patients who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment.
- Patients with valvular disease caused by failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve, and who are unable to undergo surgery, and whom are determined that the therapy using this product is the most suitable treatment. 34 mm size TAV is only for the native aortic.

Exclusion Criteria

none

Study & Design

• Study Type: Observational
• Study Design: Not specified