Bicuspid Aortic ValveNCT05836363
Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
An observational study of Bicuspid Aortic Valve and Ascending Aorta Aneurysm, run by Michele De Bonis at 1 site in Italy.
Trial summary
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bicuspid Aortic Valve, Ascending Aorta Aneurysm
- What is being tested?
- Ascending aorta replacement
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 4 Dec 2020to 9 Dec 2020
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with bicuspid aortic valve and supra-coronaric ascending aorta aneurysm requiring ascending aorta replacement. Aortic valve regurgitation is no more than moderate, so it is left untreated following the guidelines.
Who may be able to join
- Adult patients;
- Bicuspid aortic valve;
- Presence of ascending aortic aneurysm in the supra-coronary tract treated with replacement using a prosthetic tube between 2002 and January 2020;
- Untreated aortic valve disease of no more than moderate degree (<2+) at the time of ascending aorta surgery.
Who cannot join
- Emergency/urgency procedures;
- Presence of aneurysm extending to the aortic arch or aortic root, with indication for aortic root or aortic arch surgery;
- Tricuspid aortic valve tricuspid;
- Absence of aortic valve disease;
- Presence of moderate-severe or severe aortic valve disease, with indication to a concomitant aortic valve replacement.
Trial locations and contacts
1 site in 1 country.
About this study
Aortic valve bicuspid disease is the most common congenital heart disease. It affects 0.5-2% of the population and is associated with an increased risk of developing aortic or ascending aortic valve complications.
There is no agreement regarding the opportunity for a "prophylactic" simultaneous aortic valve replacement in the case of mild or moderate aortic valve disease in the bicuspid valve, in patients with an indication for replacement of the ascending aorta due to an aneurysm involving its supra-coronary tract.
The aim of this study is to evaluate the long-term evolution of mild and moderate aortic valve disease in untreated bicuspid valve during supracoronary ascending aortic replacement surgery at our institution.
- Conditions
- Bicuspid Aortic Valve, Ascending Aorta Aneurysm
- Being tested
- Ascending aorta replacement
- Medical subject headings
- Bicuspid Aortic Valve Disease, Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascending aorta replacementProcedure or surgery
The aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic valve regurgitation
Measured: Through study completion, a minimum of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start4 Dec 2020
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bicuspid Aortic ValveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michele De Bonis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michele De Bonis, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836363
- Sponsor's protocol ID
- NO SVAO-BAV
- Status last verified
- Apr 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No