CORONATE: CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05714293

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Valve Diseases Aortic Valve Stenosis Aortic Valve Insufficiency Regurgitation, Aortic Stenoses, Aortic Aortic Regurgitation Aortic Stenosis, Severe Coronary; Obstruction Valve Disease, Aortic	Radiation: CT scan with contrast medium	N/A

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 or surgical technique used (infra-annular or supra-annular technique).

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Actual Study Start Date :

Jan 11, 2023

Anticipated Primary Completion Date :

Nov 10, 2023

Anticipated Study Completion Date :

Jan 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Surgical Aortic Valve Replacement Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.	Radiation: CT scan with contrast medium Multislice CT scan (if possible retrospectively EKG-gated) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement. Other Names: CT scan

Arm

Intervention/Treatment

Experimental: Surgical Aortic Valve Replacement

Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.

Radiation: CT scan with contrast medium

Multislice CT scan (if possible retrospectively EKG-gated) with contrast medium injection of nonionic contrast agent. All CT datasets will be analysed for the qualitative and quantitative assessment of the aortic root. The coronary height will be assessed at baseline in relation to the aortic annulus and in relation to the stent of the bioprostheses after aortic valve replacement.

Other Names:

CT scan

Outcome Measures

Primary Outcome Measures

Coronary ostia height differences. [At least 90 days after surgery]
Differences in coronary ostia height before and after surgical aortic valve replacement.

Secondary Outcome Measures

Coronary ostia height differences between different bioprostheses. [At least 90 days after surgery]
Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.
Coronary ostia height differences between different surgical techniques. [At least 90 days after surgery]
Differences in coronary ostia height before and after surgical aortic valve replacement according to different surgical technique used.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 18 years;
Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
CT imaging of the thorax with iodinated contrast agent carried out before surgery;
Signed informed consent, inclusive of release of medical information.

Exclusion Criteria:

Aortic valve replacement in bicuspid valve or endocarditis;
Aortic valve replacement associated with surgery of ascending aorta/aortic root;
Aortic valve replacement associated with other cardiac valve surgery;
Previous cardiac surgery of any kind;
Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
Participation in another clinical trial that could interfere with the endpoints of this study;
Pregnant or breastfeeding at time of screening;
Allergy or hypersensitivity to iodinated contrast agent;
End-stage renal disease on dialysis.
Childbearing-aged women or men with childbearing-aged partner.