CT-evaluation of Coronary Ostia Height After Surgical Aortic... | Clinical Trial | StuddyBuddy@endsection CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.
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Enrolling By Invitation NCT05714293

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

Conditions: Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency, Regurgitation, Aortic, Stenoses, Aortic, Aortic Regurgitation, Aortic Stenosis, Severe, Coronary; Obstruction, Valve Disease, Aortic

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 90
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Location: Italy

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 Criteria

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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05714293). StuddyBuddy aggregates publicly available trial information.