Aortic Stenosis, SevereCONTINUUM-CTNCT06596460
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
A study testing TAVI planning CT (adapted) in people with Aortic Stenosis, Severe and Aortic Valve Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Severe, Aortic Valve Stenosis
- What is being tested?
- TAVI planning CT (adapted)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jul 2024to 12 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
- CT TAVI deemed of good quality (as per standard operating procedure) within past 6 months
- TTE of good quality within past 6 months as defined by:
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- Doppler signal across the aortic valve and LVOT is a clear and artifact-free waveform
- Correct alignment to the blood flow direction to ensure accurate velocity measurements
- Following measurements available
- Continuous-wave Doppler (CW) across the aortic valve
- AV Vmax, AV Vmean, AV peak gradient (MaxPG), AV mean gradient (meanPG), AV Velocity-Time integral (VTI), heart rate (HR);
- Pulse-wave Doppler (PW) across the LVOT
- LVOT Vmax, LVOT Vmean, LVOT MaxPG, LVOT meanPG, LVOT VTI;
- 2D LVOT diameter in plax view.
- In sinus rhythm at time of any TTE or CT scans
- Undergone a technically successful elective TAVI as defined by the operator using a Edwards Sapien 3 Ultra (20, 23, 26 or 29 mm):
- Position and height as planned
- Trivial aortic regurgitation
- No vascular or other complications prolonging discharge
Who cannot join
- 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
- Previous TAVI or Aortic Valve Replacement (AVR)
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- Left Ventricular Ejection Fraction (LVEF) < 50%
- On or planned oral anticoagulation
- Chronic severe renal failure (estimated glomerule filtration rate (eGFR)) less than 30 mL/min/1.73m2 by the MDRD equation or requiring dialysis)
- Evidence of an acute myocardial infarction within 30 days prior to index procedure
- Untreated clinically significant coronary artery disease requiring revascularization
- Blood dyscrasias as defined: leukopenia (WBC < 3000mm3), acute anaemia (Hb < 9g/dL), thrombocytopenia (platelet count < 50,000 cells/mm3); history of bleeding diathesis or coagulopathy
- Active peptic ulcer or upper GI bleeding within 3 months prior to index procedure that would preclude anticoagulation
- Those lacking capacity to consent or are deemed vulnerable adults
- Requires permanent pacemaker
- Pregnancy or the possibility of pregnancy as reported by the participant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomew's Hospital
London, England, EC1A 7BE
R&D Governance Administrator, +44 (0)20 7882 6826, research.governance@qmul.ac.uk
Ruth Bowles, +44 (0) 20 34656213, ruth.bowles1@nhs.net
About this study
Official title: Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
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.
Read more
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
- Aortic Stenosis, Severe, Aortic Valve Stenosis
- Being tested
- TAVI planning CT (adapted)
- Keywords
- Heart, Valve, Implantation, Transcatheter, CT, Computerised Tomography
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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. There will be no requirement to scan the ilio-femoral arteries as per standard TAVI planning CT
| Study group | Role | What they receive |
|---|---|---|
| Computerised Tomography (CT) Intervention | Experimental | Transpercutaneous Aortic Valve Implantation (TAVI) planning CT (adapted) of the heart and aortic arch at 6 months post TAVI Receives: Diagnostic Test: TAVI planning CT (adapted) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 months
Secondary outcomes (5)
The occurrence of Patient/Prosthesis mismatch (PPM) - as measured by a transvalvular gradient >10 mmHg
Measured: At Day 1 post TAVI
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
Measured: At Day 1 post TAVI and 6 months
The occurrence of hypo attenuated leaflet thickening (HALT) as reported by radiologist utilising CT scan
Measured: At 6 months
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
Measured: At baseline and at 6 months
The occurrence of major adverse cardiac events (MACE) (defined as: cardiovascular death, stroke, myocardial infarction and cardiac reintervention [including stent insertion])
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Jul 2024
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Stenosis, SevereStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single centre, prospective, interventional study in 40 patients undergoing TAVI in a National Health Service (NHS) hospital
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Anthony Mathur, Prof, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596460
- Sponsor's protocol ID
- 164073
- Acronym
- CONTINUUM-CT
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT06596460
- Acronym / sponsor ID
- CONTINUUM-CT / 164073
- Conditions
- Aortic Stenosis, Severe, Aortic Valve Stenosis
- Keywords
- Heart, Valve, Implantation, Transcatheter, CT, Computerised Tomography
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single centre, prospective, interventional study in 40 patients undergoing TAVI in a National Health Service (NHS) hospital
| Arm | Type | Receives |
|---|---|---|
| Computerised Tomography (CT) Intervention | Experimental | Diagnostic Test: TAVI planning CT (adapted)Transpercutaneous Aortic Valve Implantation (TAVI) planning CT (adapted) of the heart and aortic arch at 6 months post TAVI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥ 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
- CT TAVI deemed of good quality (as per standard operating procedure) within past 6 months
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAVI planning CT (adapted)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. There will be no requirement to scan the ilio-femoral arteries as per standard TAVI planning CT | Diagnostic test | Computerised Tomography (CT) Intervention |
Primary outcome
The number of participants with quality TAVI CT imaging data post TAVI procedure.
Time frame: At 6 months
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.
5 secondary outcomes
The occurrence of Patient/Prosthesis mismatch (PPM) - as measured by a transvalvular gradient >10 mmHg
Time frame: At Day 1 post TAVI
The occurrence of haemodynamic valve deterioration as measured by Transthoracic echocardiography (TTE)
Time frame: At Day 1 post TAVI and 6 months
The occurrence of hypo attenuated leaflet thickening (HALT) as reported by radiologist utilising CT scan
Time frame: At 6 months
Change in New York Heart Association (NYHA) class score I to IV
Time frame: At baseline and at 6 months
The occurrence of major adverse cardiac events (MACE) (defined as: cardiovascular death, stroke, myocardial infarction and cardiac reintervention [including stent insertion])
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anthony Mathur, Prof principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAVI planning CT (adapted) in people with Aortic Stenosis, Severe and Aortic Valve Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact R&D Governance Administrator (+44 (0)20 7882 6826, research.governance@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with quality TAVI CT imaging data post TAVI procedure. (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.