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Collecting heart scans before and after valve replacement for severe aortic stenosis

Collects CT scan data to help predict valve performance in 40 patients.

Key facts

Who runs it
Barts & The London NHS Trust
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Status
Recruiting
People taking part
40 people, planned
Started
9 Jul 2024
Expected to end
12 Dec 2026
Type of study
Interventional
Treatments tested
  • TAVI planning CT (adapted)
Record updated
2 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with severe, symptomatic aortic stenosis (a narrowed heart valve) who have had a successful planned TAVI valve procedure. They will have an extra CT scan 6 months after TAVI.

Age
18 years or older
Sex
All sexes
Disease stage
Symptomatic, degenerative, severe aortic stenosis with a three-leaflet (tricuspid) valve. Heart echo shows valve area ≤ 1.0 cm2 (or EOAi ≤ 0.6 cm2 /m2), and mean gradient ≥ 40 mmHg or peak jet velocity ≥ 4.0 m/s or DVI ≤ 0.25. Normal heart rhythm (sinus rhythm) during scans.
Earlier treatment
Must have had a technically successful elective TAVI with an Edwards Sapien 3 Ultra valve (20, 23, 26 or 29 mm). Must have a good-quality CT and heart echo within the past 6 months. People who had TAVI or aortic valve replacement before cannot join.

Main reasons for not taking part

  • Life expectancy under 6 months or Rockwood frailty score above 6
  • Born with a one- or two-leaflet aortic valve, or significant other valve disease
  • Heart pumping strength (LVEF) below 50%, or needing a permanent pacemaker
  • Taking or planned to take blood thinners by mouth, or bleeding or blood disorders
  • Severe kidney failure (eGFR less than 30 mL/min/1.73m2) or on dialysis; pregnancy or possible pregnancy

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • ≥ 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

Who cannot take part

  • Previous TAVI or Aortic Valve Replacement (AVR)
  • Evidence of an acute myocardial infarction within 30 days prior to index procedure
  • Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
  • Mixed aortic valve disease with predominant aortic regurgitation that is at least moderate
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Left Ventricular Ejection Fraction (LVEF) < 50%
  • Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL/min/1.73m2 by the MDRD equation or requiring dialysis)
  • 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
  • Life expectancy <6 months
  • Rockwood frailty score >6
  • Moderate-severe mitral regurgitation and/or mitral stenosis
  • Congenital unicuspid or congenital bicuspid aortic valve as verified by echocardiography or CT
  • On or planned oral 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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 patients with severe Aortic Stenosis (AS) will be asked to take part.

The data from the scans along with routine measures that are taken will be used to assess if there has been any deterioration in the valve at six months.

The scan data collected will be used in a computer programme. This programme will be trained to predict TAVI valve performance.

The main purpose of this study is to collect the CT scan data before and after the TAVI procedure.

The study aims to answer:

• Can the investigators obtain additional CT imaging data and other data before and after TAVI to enable the prediction of valve performance?

Participants will be asked if they would have another CT scan 6 months after their TAVI procedure, during their routine follow up.

The group in the trial

  • Computerised Tomography (CT) InterventionTreatment being tested

    Transpercutaneous Aortic Valve Implantation (TAVI) planning CT (adapted) of the heart and aortic arch at 6 months post TAVI

    Treatment: TAVI planning CT (adapted)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
Plain-language title
Collecting heart scans before and after valve replacement for severe aortic stenosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
2 October 2026