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

Eunpyeong St. Mary's Hospital

Status: Enrolling

Conditions: Aortic Stenosis

Treatments: Device: Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves

Study type: Observational

Funder types: Other

Identifiers

NCT06722066

PC24OISI0131

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 19 years or older.
2. Patients who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis.
3. Individuals who have voluntarily provided written informed consent to participate.

Exclusion criteria

1. Individuals who have not provided written informed consent for this study.