MedTrace Logo

Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: SAINT-TAVR Calcium Registry

NCT06722066 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-12-09

No results posted yet for this study

Summary

The goal of this observational study is to learn about the long-term effects of aortic valve annular calcification in patients undergoing transcatheter aortic valve replacement (TAVR). The main question it aims to answer is:

Does the degree of aortic valve annular calcification prior to TAVR influence long-term clinical outcomes, including major adverse cardiovascular events including all-cause mortality, over a 3-year period?

Participants who have undergone TAVR as part of their regular medical care for severe aortic stenosis will have their pre-procedural imaging and clinical outcomes evaluated for a 3-year follow-up period.

Conditions

  • Aortic Stenosis

Interventions

DEVICE

Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves

Device: Edwards SAPIEN 3 valve, Medtronic Evolut valve, Boston Acurate Neo valve, or Abbott Navitor Access route: transfemorak, subclavian, transapical, transcarotid, or transcaval The use of balloon dilation will be left to the discretion of the operator.

Sponsors & Collaborators

  • Eunpyeong St. Mary's Hospital

    lead OTHER

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-02
Primary Completion
2031-12-02
Completion
2034-10-02
FDA Device
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06722066 on ClinicalTrials.gov