ClinicaliQ Trial Snapshot
- A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI) — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT06596460.
- What is being tested: The study evaluates whether pre-procedure CT scans and transthoracic echocardiography (TTE) can accurately predict outcomes and guide patient selection for Transcatheter Aortic Valve Implantation (TAVI), a minimally invasive aortic valve replacement procedure.
- Patient eligibility overview: The trial involves 40 patients who are candidates for TAVI procedures and have undergone both CT imaging and transthoracic echocardiography prior to their scheduled valve implantation.
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- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
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What This Trial Is Studying
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used to predict how the new TAVI valve will perform in the future. To do this the investigators need the usual CT scan before and a new CT scan after the TAVI valve has been put in. At present a CT scan after TAVI procedure is not routinely done. Male and female…
Eligibility Snapshot
- : * ≥ 18 years of age * Symptomatic, degenerative, tricuspid, severe aortic stenosis * TTE derived aortic valve area (AVA) of ≤ 1.0 cm2 (or indexed effective orifice area (EOAi) ≤ 0.6 cm2 /m2) * TTE derived AV mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or Doppler Velocity Index (DVI) ≤ 0.25 * CT TAVI deemed of good quality (as per standard operating procedure) within past 6 months * TTE of good quality within past 6 months as defined by: * Doppler signal across the aortic valve and LVOT is a clear and artifact-free waveform * Correct alignment to the blood flow direction to ensure accurate velocity measurements * Following measurements available * Continuous-wave Doppler (CW) across the aortic valve * AV Vmax, AV Vmean, AV peak gradient (MaxPG), AV mean gradient (meanPG), AV Velocity-Time integral (VTI), heart rate (HR); * Pulse-wave Doppler (PW) across the LVOT * LVOT Vmax, LVOT Vmean, LVOT MaxPG, LVOT meanPG, LVOT VTI; * 2D LVOT diameter in plax view. * In sinus rhythm at time of any TTE or CT scans * Undergone a technically successful elective TAVI as defined by the operator using a Edwards Sapien…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.