Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 11:40 AM
Study NCT ID:
NCT05714293
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-15
First Post:
2023-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Study Overview
Official Title:
CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
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:
CORONATE
Brief Summary:
The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.
Detailed Description:
Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.
Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.
All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.
Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.
All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.
Study Oversight
Has Oversight DMC:
None
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?: