Actively Recruiting
Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
Led by Barts & The London NHS Trust · Updated on 2025-09-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Barts & The London NHS Trust
Lead Sponsor
Q
Queen Mary University of London
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with severe aortic stenosis to find out if CT scans and heart echo scans taken before a Transcatheter Aortic Valve Implantation (TAVI) can help predict how well the new valve will work over time. This study focuses on collecting detailed imaging data before and after the TAVI procedure to improve predictions of valve performance using a computer program. Participants will have a CT scan before their TAVI procedure and another CT scan six months after the procedure, which is not normally done. The study involves using these scans along with routine measures to assess any changes or deterioration in the valve. Data collected will train an algorithm to predict TAVI valve outcomes. During the study, participants will undergo imaging tests including CT and transthoracic echo scans around the time of their TAVI and at six months follow-up. Researchers will monitor valve function and complications using these images and routine clinical measures. The main outcome is obtaining quality CT imaging data at six months, with additional assessments of valve function and heart health during follow-up. Participation lasts through the six-month post-TAVI period.
CONDITIONS
Brief Title
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Symptomatic, degenerative, tricuspid, severe aortic stenosis
- Aortic valve area of 1.0 cm2 or less (or indexed effective orifice area 0.6 cm2/m2 or less) by transthoracic echocardiography
- Aortic valve mean gradient 40 mmHg or more, or peak jet velocity 4.0 m/s or more, or Doppler Velocity Index 0.25 or less
- Good quality CT TAVI scan within past 6 months
- Good quality transthoracic echocardiogram within past 6 months with clear Doppler signals and specific velocity and gradient measurements
- In sinus rhythm at time of TTE or CT scans
- Successfully undergone elective TAVI using Edwards Sapien 3 Ultra valve with planned position and trivial aortic regurgitation
- No vascular or other complications prolonging hospital discharge
You will not qualify if you...
- Life expectancy less than 6 months
- Rockwood frailty score greater than 6
- Mixed aortic valve disease with moderate or worse aortic regurgitation
- Moderate to severe mitral regurgitation or mitral stenosis
- Congenital unicuspid or bicuspid aortic valve
- Previous TAVI or aortic valve replacement
- Left ventricular ejection fraction less than 50%
- Currently on or planning to start oral anticoagulation
- Severe chronic kidney failure (eGFR less than 30 mL/min/1.73m2) or on dialysis
- Acute myocardial infarction within 30 days before procedure
- Untreated significant coronary artery disease needing revascularization
- Blood disorders affecting white cells, red cells, or platelets
- Active peptic ulcer or upper gastrointestinal bleeding within 3 months
- Lack capacity to consent or considered vulnerable adult
- Requires permanent pacemaker
- Pregnancy or possibility of pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At 6 months post TAVI
Participants undergo a specialized planning CT scan adapted for Transcatheter Aortic Valve Implantation (TAVI) to assess the heart and aortic arch at 6 months post TAVI.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
St Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Actively Recruiting
Research Team
R
R&D Governance Administrator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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