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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
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
Where Is This Study? (1 UK site)
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
How to Get in Touch
R&D Governance Administrator
Sponsor contactCONTACT
