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

NCT07509554 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-04-03

No results posted yet for this study

Summary

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.

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

Transcatheter aortic valve replacement (TAVR / TAVI)

TAVI is performed as per standard procedural guidelines

Sponsors & Collaborators

  • Istanbul Mehmet Akif Ersoy Educational and Training Hospital

    lead OTHER_GOV

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2028-07-30
Completion
2029-08-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509554 on ClinicalTrials.gov