CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement. (CORONATE)
Heart Valve Diseases, Aortic Valve Stenosis, Aortic Valve Insufficiency
About this trial
This is an interventional basic science trial for Heart Valve Diseases focused on measuring Aortic valve replacement, Aortic valve bioprosthesis, Coronary ostia obstruction, Valve-in-valve, Transcatheter aortic valve implantation, Aortic valve stenosis, Tricuspid aortic valve, Aortic valve regurgitation, CT coronary angiogram, Transcatheter aortic valve replacement
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.
Sites / Locations
- Policlinico Agostino Gemelli
Arms of the Study
Arm 1
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.