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.
Age 60-90 years.
Active infection, uncontrolled systemic disease, active malignancy, or life expectancy < 1 month.
Consecutive patients with inclusion criteria who are clinical candidates for TAVI based on multidisciplinary heart team evaluation.
Cohort
Prospective
Transcatheter aortic valve replacement (TAVR / TAVI)
Procedure/SurgeryTAVI is performed as per standard procedural guidelines
EQ-5D-5L
The 5-level EQ-5D version (EQ-5D-5L) measures health related quality of life
MACE
MACE (defined by VARC-3) will be monitored via electronic health records and telephone-visits.
WIA
Wave Intensity Analysis (WIA): By analyzing simultaneous changes in pressure and flow (or flow-surrogates), WIA identifies the energy flux of forward and backward-traveling waves with their temporal and amplitude features.
REPA
Reservoir-Excess Pressure Analysis (REPA): This method decomposes the measured aortic pressure waveform into a reservoir pressure (Pr), reflecting the global arterial storage and compliance dynamics, and an excess pressure (Pxs), representing the dynamic, wave-related component of the pulse. Parameters such as P-infinity (Pinf) serve as proxies for microcirculatory closing pressures.
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This trial is not recruiting at the moment. You can still explore other options:
