St Bartholomew's Hospital
London, England, EC1A 7BE, United Kingdom
Location status: Recruiting
Location contact
Anthony Mathur, Prof
PRINCIPAL_INVESTIGATOR
R&D Governance Administrator
CONTACT
Ruth Bowles
CONTACT
NCT Number: NCT06596460
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
London, England, EC1A 7BE, United Kingdom
Location status: Recruiting
Anthony Mathur, Prof
PRINCIPAL_INVESTIGATOR
R&D Governance Administrator
CONTACT
Ruth Bowles
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: At Day 1 post TAVI
Time frame: At Day 1 post TAVI and 6 months
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 6 months
Time frame: At baseline and at 6 months
NYHA functional classification of heart failure classes I to IV where I is best and IV is worst
Time frame: At 6 months
Contact information is provided by the study sponsor or research team.
Barts & The London NHS Trust
Other
Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
Acronym: CONTINUUM-CT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05714293
Aortic Regurgitation, Aortic Stenosis, Severe
Roma, Italy
View Trial DetailsNCT05536310
Aortic Stenosis, Severe, Aortic Valve Disease
Bad Oeynhausen, Germany
View Trial DetailsNCT05172960
Aortic Stenosis, Severe, Aortic Valve Disease
La Jolla, California, United States
View Trial DetailsNCT06377449
Aneurysm, Aneurysm, Ascending Aorta
Saint Petersburg, Sankt-Peterburg, Russia
View Trial Details