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

Recruiting

• Conditions: Aortic Stenosis

• Registration Number: NCT06722066
• Lead Sponsor: Eunpyeong St. Mary's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-10-02
• Status Verified: 2024-12
• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2031-12-02
• Study Completion: 2034-10-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	3 years follow-up

Secondary Outcome Measures

Name	Time	Method
Hospitalization for heart failure	3 years follow-up
Stroke	3 years follow-up
Myocardial infarction	3 years follow-up
Permanent pacemaker insertion	3 years follow-up
Vascular complication	30 days follow-up

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of