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

Impact of Aortic Annulus Calcification on Long-Term Outcomes Following Transcatheter Aortic Valve Replacement: Scientific Association of Interventional Cardiology - Transcatheter Aortic Valve Replacement (SAINT-TAVR) Calcium Registry

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06722066

Acronym

SAINT-TAVR Ca

Enrollment

500

Registered

2024-12-09

Start date

2024-10-02

Completion date

2034-10-02

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

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.

Interventions

DEVICETranscatheter 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
All-cause mortality	3 years follow-up

Secondary

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

Other

Measure	Time frame
Echo parameters	annual follow-up until 3 years

Countries

South Korea

Contacts

Primary ContactOsung Kwon, MD. PhD

oscaesar@gmail.com+82-10-3708-5673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026