Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06596460

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

Led by Barts & The London NHS Trust · Updated on 2025-09-03

40

Participants Needed

1

Research Sites

113 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Symptomatic, degenerative, tricuspid, severe aortic stenosis
  • Aortic valve area (AVA) of 1.0 cm2 or less (or indexed effective orifice area 0.6 cm2/m2 or less) from heart ultrasound
  • Aortic valve mean gradient of 40 mmHg or higher, or peak jet velocity of 4.0 m/s or higher, or Doppler Velocity Index of 0.25 or less
  • CT scan for TAVI planning of good quality within past 6 months
  • Heart ultrasound of good quality within past 6 months with clear Doppler signals and specific velocity measurements
  • Sinus rhythm at time of any heart ultrasound or CT scans
  • Successful elective TAVI with Edwards Sapien 3 Ultra valve, with correct valve position and height, trivial aortic regurgitation, and no complications delaying discharge
Not Eligible

You will not qualify if you...

  • Life expectancy less than 6 months
  • Frailty score higher than 6
  • Mixed aortic valve disease with moderate or worse aortic regurgitation
  • Moderate to severe mitral valve regurgitation or mitral stenosis
  • Congenital unicuspid or bicuspid aortic valve
  • Previous TAVI or aortic valve replacement
  • Left ventricular ejection fraction below 50%
  • Current or planned use of oral anticoagulation
  • Severe chronic kidney failure with eGFR less than 30 mL/min/1.73m2 or requiring dialysis
  • Heart attack within 30 days before the procedure
  • Untreated significant coronary artery disease
  • Blood disorders including low white blood cells, acute anemia, low platelets, bleeding disorders
  • Active peptic ulcer or upper gastrointestinal bleeding within 3 months before procedure
  • Unable to consent or vulnerable adults
  • Require a permanent pacemaker
  • Pregnant or possibly pregnant

AI-Screening

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Trial Site Locations

Total: 1 location

1

St Bartholomew's Hospital

London, England, United Kingdom, EC1A 7BE

Actively Recruiting

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Research Team

R

R&D Governance Administrator

CONTACT

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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