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Recruiting NCT06722066

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

— Observational Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official 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

Overview

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

  • Device Transcatheter 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.

Primary outcome measures

  • All-cause mortality [Time frame: 3 years follow-up]
Secondary outcome measures (5)
  • Hospitalization for heart failure [Time frame: 3 years follow-up]
  • Stroke [Time frame: 3 years follow-up]
  • Myocardial infarction [Time frame: 3 years follow-up]
  • Permanent pacemaker insertion [Time frame: 3 years follow-up]
  • Vascular complication [Time frame: 30 days follow-up]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Division of Cardiology, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, Co — Seoul

Identifiers

NCT: NCT06722066 · PC24OISI0131

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗