AI trained on scans could predict TAVI valve success
NCT ID NCT06596460
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study aims to see if CT and echo scans taken before and after a TAVI procedure can help predict how the new heart valve will perform. Researchers will collect scan data from 40 adults with severe aortic stenosis and use it to train a computer algorithm. The goal is to improve future valve assessments, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TAVI planning CT (adapted)
- What this could lead to
- If successful, this could lead to a computer tool that helps doctors predict how well a TAVI valve will perform after implantation.
- What could go wrong
- This is a small, early study with only 40 participants. It is designed to collect data, not to test a treatment, so it may not lead to a usable prediction tool.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * ≥ 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 3 Ultra (20, 23, 26 or 29 mm): * Position and height as planned * Trivial aortic regurgitation * No vascular or other complications prolonging discharge Exclusion Criteria: * Life expectancy \<6 months * Rockwood frailty score \>6 * Mixed aortic valve disease with predominant aortic regurgitation that is at least moderate. * Moderate-severe mitral regurgitation and/or mitral stenosis. * Congenital unicuspid or congenital bicuspid aortic valve as verified by echocardiography or CT * Previous TAVI or Aortic Valve Replacement (AVR) * Left Ventricular Ejection Fraction (LVEF) \< 50% * On or planned oral anticoagulation * Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL/min/1.73m2 by the MDRD equation or requiring dialysis) * Evidence of an acute myocardial infarction within 30 days prior to index procedure * Untreated clinically significant coronary artery disease requiring revascularization * Blood dyscrasias as defined: leukopenia (WBC \< 3000mm3), acute anaemia (Hb \< 9g/dL), thrombocytopenia (platelet count \< 50,000 cells/mm3); history of bleeding diathesis or coagulopathy * Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation * Those lacking capacity to consent or are deemed vulnerable adults * Requires permanent pacemaker * Pregnancy or the possibility of pregnancy as reported by the participant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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St Bartholomew's Hospital
RECRUITINGLondon, England, EC1A 7BE, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Which heart valve design wins for small aortic openings?
- Can a less invasive valve replacement tame a failing aortic valve?
- Can a new heart valve match the safety of proven ones?