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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fate at Long-term of Mild to Moderate Bicuspid Aortic Valve Disease Left Untreated at the Time of Supracoronary Ascending Aorta Replacement
- ClinicalTrials.gov ID
- NCT05836363
- Acronym / sponsor ID
- NO SVAO-BAV
- Conditions
- Bicuspid Aortic Valve, Ascending Aorta Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Michele De BonisUniversity, hospital or other
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascending aorta replacementThe aneurysmatic ascending aorta tract is replaced with a tubular dacron prosthesis | Procedure or surgery | – |
Primary outcome
Aortic valve regurgitation
Time frame: Through study completion, a minimum of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bicuspid Aortic Valve and Ascending Aorta Aneurysm, run by Michele De Bonis at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic valve regurgitation (time frame: Through study completion, a minimum of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.