A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarts & The London NHS Trust
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.
Eligibility criteria
Qualifiers
≥ 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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TAVI planning CT (adapted)
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Barts & The London NHS Trust
Lead sponsor
Queen Mary University of London
Collaborator
Source ClinicalTrials.gov