Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT06596460
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
Sponsor:
Barts & The London NHS Trust
Organization:
Study Overview
Official Title:
Single Centre Prospective Study to Obtain Data to Train an Algorithm for Prediction of Outcome in Transcatheter Aortic Valve Implantation (TAVI)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONTINUUM-CT
Brief 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.
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: