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| Name | Class |
|---|---|
| Queen Mary University of London | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerised Tomography (CT) Intervention | Experimental | Transpercutaneous Aortic Valve Implantation (TAVI) planning CT (adapted) of the heart and aortic arch at 6 months post TAVI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of Patient/Prosthesis mismatch (PPM) - as measured by a transvalvular gradient >10 mmHg | 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 |
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Inclusion Criteria:
≥ 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:
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):
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| R&D Governance Administrator | Contact | +44 (0)20 7882 6826 | research.governance@qmul.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Anthony Mathur, Prof | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | Recruiting | London | England | EC1A 7BE | United Kingdom |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000064 | Acclimatization |
| ID | Term |
|---|---|
| D000222 | Adaptation, Physiological |
| D010829 | Physiological Phenomena |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
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A single centre, prospective, interventional study in 40 patients undergoing TAVI in a National Health Service (NHS) hospital
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|
| At Day 1 post TAVI and 6 months |
| The occurrence of hypo attenuated leaflet thickening (HALT) as reported by radiologist utilising CT scan | 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 | 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]) | At 6 months |
| D014694 |
| Ventricular Outflow Obstruction |