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
This trial does not accept healthy volunteersQualifiers
≥ 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
Design model
Single group
Treatments tested in this trial
TAVI planning CT (adapted)
Diagnostic testTAVI 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. There will be no requirement to scan the ilio-femoral arteries as per standard TAVI planning CT
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Computerised Tomography (CT) InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of participants with quality TAVI CT imaging data post TAVI procedure.
Quality (high-good resolution and without artifacts) retrospectively ECG-gated scan of the heart, aortic annulus and ascending aorta to the first branch vessel. The full body angiogram, best systole and best diastole must be present.
Time frame
At 6 monthsSecondary outcomes
1
The occurrence of Patient/Prosthesis mismatch (PPM) - as measured by a transvalvular gradient >10 mmHg
Time frame
At Day 1 post TAVI2
The occurrence of haemodynamic valve deterioration as measured by Transthoracic echocardiography (TTE)
Routine measures of Transthoracic echocardiography (TTE) to determine the occurrence of haemodynamic valve deterioration as defined by Valve Academic Research Consortium (VARC -3) criteria
Time frame
At Day 1 post TAVI and 6 months3
The occurrence of hypo attenuated leaflet thickening (HALT) as reported by radiologist utilising CT scan
Time frame
At 6 months4
Change in New York Heart Association (NYHA) class score I to IV
NYHA functional classification of heart failure classes I to IV where I is best and IV is worst
Time frame
At baseline and at 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Barts & The London NHS Trust
Lead sponsor
Queen Mary University of London
Collaborator
Source ClinicalTrials.gov