Heart Diseases Clinical Trial
— ARDITAVOfficial title:
Progression of the Ascending Aorta Diameter After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve.
NCT number | NCT05708118 |
Other study ID # | 5239 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 20, 2023 |
Est. completion date | January 21, 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 21, 2024 |
Est. primary completion date | January 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Bicuspid 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Policlinico Agostino Gemelli | Roma |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Italy,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ascending aorta diameters changes. | Evaluation of ascending aorta diameters after transcatheter or surgical aortic valve replacement highlighted by both CT and echocardiographic assessment. | At least 90 days after intervention. |
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