Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical… (NCT05708118) | Clinical Trial Compass
UnknownNot Applicable
Progression of Ascending Aorta Diameters in Bicuspid Aortic Valve After Transcatheter or Surgical Replacement.
Italy150 participantsStarted 2023-01-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.