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

December 3, 2024 updated by: Osung Kwon, Eunpyeong St. Mary's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 122-200
        • Recruiting
        • Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults aged 19 years or older who have undergone transcatheter aortic valve replacement (TAVR) for severe aortic stenosis and have voluntarily expressed their willingness to participate through written informed consent.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause mortality
Time Frame: 3 years follow-up
3 years follow-up

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Echo parameters
Time Frame: annual follow-up until 3 years
annual follow-up until 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eunpyeong St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2024

Primary Completion (Estimated)

December 2, 2031

Study Completion (Estimated)

October 2, 2034

Study Registration Dates

First Submitted

December 3, 2024

First Submitted That Met QC Criteria

December 3, 2024

First Posted (Estimated)

December 9, 2024

Study Record Updates

Last Update Posted (Estimated)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PC24OISI0131

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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