Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06722066

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, 122-200, South Korea

Location status: Recruiting

Location contact

Hye-Yeon Seo, A Master´s degree

CONTACT

[email protected]

+82-10-9151-9028

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Device

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.

Primary outcomes

  1. All-cause mortality

    Time frame: 3 years follow-up

Secondary outcomes

  1. Hospitalization for heart failure

    Time frame: 3 years follow-up

  2. Stroke

    Time frame: 3 years follow-up

  3. Myocardial infarction

    Time frame: 3 years follow-up

  4. Permanent pacemaker insertion

    Time frame: 3 years follow-up

  5. Vascular complication

    Time frame: 30 days follow-up

Other outcomes

  1. Echo parameters

    Time frame: annual follow-up until 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Osung Kwon, MD. PhD

CONTACT

[email protected]

+82-10-3708-5673

Sponsors and collaborators

Lead sponsor

Eunpyeong St. Mary's Hospital

Other

Registry information

Official study title

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

Acronym: SAINT-TAVR Ca

Important dates

Study start
2024
Primary completion
2031
Study completion
2034
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.