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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Transcatheter aortic valve replacement with ballon-expandable or self-expandable valves
DeviceDevice: 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
Trial outcomes
Primary outcomes
All-cause mortality
Secondary outcomes
Hospitalization for heart failure
Stroke
Myocardial infarction
Permanent pacemaker insertion
Other outcomes
Echo parameters
Sponsors and contacts
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