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NCT05708118
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
Conditions: Bicuspid Aortic Valve, Aortic Valve Stenosis, Aortic Aneurysm, Heart Diseases, Valvular Heart Disease, Valvular Aortic Stenosis, Ascending Aorta Aneurysm
Sex: All
Ages: 18 Years – N/A
Enrollment: 150
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Location: Italy
Summary
The goal of this prospective, non-randomized, single-center, observational study is to assess whether there is a progressive dilation of ascending aorta after surgical or transcatheter aortic valve replacement (TAVR) in patients who underwent elective aortic valve replacement or TAVR for stenotic bicuspid aortic valve (BAV) at our institution from 2015 to June 2022.Participants will undergo both a CT and an echocardiographic assessment at least 90 days after surgery.
Eligibility Criteria
Inclusion Criteria:Age ≥ 18 yearsBicuspid aortic valve stenosis treated with surgical or transcatheter aortic valve replacement;Concomitant ascending aorta aneurysm, with no indication to surgical treatment at the time of intervention;Patients with indication to follow-up Chest CT angiography Scan.Signed informed consent, inclusive of release of medical information.Exclusion Criteria:Aortic valve replacement in tricuspid valves or bicuspid insufficient valves 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.
Source: ClinicalTrials.gov (NCT05708118). StuddyBuddy aggregates publicly available trial information.