Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596460
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation TAVI
Sponsor:
None
Organization:
None
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:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None