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A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)

Sponsor: Barts & The London NHS Trust

NCT ID: NCT06596460

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
TAVI planning CT (adapted) (diagnostic test)
How long the study runs
Study runs about 29 months (dates as stated)
About the drug or intervention
TAVI planning CT (adapted) — diagnostic test: TAVI planning CT (adapted) to obtain a standard assessment of the Left Ventricular Outflow Tract (LVOT), valve annulus, aortic root, and ascending aorta up to neck branches.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
40
Started
2024-07-09
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for aortic stenosis, severe
  • • NA - 40 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aortic stenosis, severe

Where?

  • • London - St Bartholomew's Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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 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.

Aortic Stenosis, SevereAortic Valve Stenosis

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFR

What the study is looking for

  • ✓≥ 18 years of age
  • ✓causing symptoms, 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

Who cannot take part

  • ✗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
See the full criteria
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.

Where Is This Study? (1 UK site)

St Bartholomew's Hospital

London EC1A 7BE, United Kingdom

Recruiting
Site contact (verified)
Anthony Mathur, ProfPrincipal Investigator

How to Get in Touch

R&D Governance Administrator

Sponsor contact

CONTACT

+44 (0)20 7882 6826 research.governance@qmul.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-10