PRessure-based Evaluation of Disease Improvement in the Course of TAVI

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-90
SponsorIstanbul Mehmet Akif Ersoy Educational and Training Hospital

About this trial

The goal of this prospective observational study is to learn if advanced heart pressure wave analysis (using methods called WIA and REPA) can help predict the success of the procedure and long-term recovery in adults (aged 60-90) with severe Aortic Stenosis who are undergoing Transcatheter Aortic Valve Replacement (TAVR/TAVI).

The main questions it aims to answer are:

Do changes in heart pressure wave patterns immediately after the new valve is implanted relate to improvements in a patient's quality of life and heart health over the following year?

Can these advanced wave measurements better predict major heart complications (MACE) at 30 days, 180 days and 1 year compared to standard clinical tests?

Participants will:

Undergo a standard TAVR (TAVI) procedure as part of their regular medical care to replace a narrowed heart valve.

Have their aortic pressure waves recorded through a catheter during the routine procedure (this happens during the surgery and does not require any additional incisions or invasive steps).

Complete quality-of-life surveys (EQ-5D-5L) and clinical assessments before the procedure.

Be followed up via telephone calls or electronic health records at 30 days, 180 days and 12 months after the procedure to check on their recovery and overall health status.

Eligibility criteria

Qualifiers

Age 60-90 years.

Disqualifiers

Active infection, uncontrolled systemic disease, active malignancy, or life expectancy < 1 month.

Trial design

Treatments tested in this trial

  • Transcatheter aortic valve replacement (TAVR / TAVI)

Treatment groups

100 Participants
are divided into 1 treatment group