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Enrolling by invitation Not applicable

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

NCT05714293 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2023-01-11
Last updated
2025-08-15

Condition(s) studied

Heart Valve DiseasesAortic Valve StenosisAortic Valve InsufficiencyRegurgitation, AorticStenoses, AorticAortic RegurgitationAortic Stenosis, SevereCoronary; ObstructionValve Disease, Aortic

Investigational drug(s) / intervention(s)

CT scan with contrast medium

CT scan with contrast medium: Multi-detector CT scan (if possible with prospective-ECG gated sequential scan) 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 at time of screening; * Allergy or hypersensitivity to iodinated contrast agent; * End-stage renal disease on dialysis.

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Policlinico Agostino Gemelli Roma Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05714293 on ClinicalTrials.gov ↗ ← All trials in Italy