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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19+
SponsorEunpyeong St. Mary's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

1

Echo parameters

Time frame
annual follow-up until 3 years

Sponsors and contacts

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