Active not recruitingOBSERVATIONAL

International Bicuspid Aortic Valve Consortium (BAVCon)

The BAVCon study is researching bicuspid aortic valve (BAV) disease, a common heart problem present at birth where the aortic valve has two flaps instead of the usual three. While often harmless in younger people, it can lead to serious issues like a bulging main artery (aorta) or problems with the valve itself later in life. We don't fully understand why BAV happens, how it gets worse, or all its genetic links. This international study brings together many hospitals to find the genetic causes of BAV and its related aortic problems. They also want to discover ways to predict how the disease will progress and find new treatments. By collecting information from patients with BAV, they hope to get a clearer picture of this condition.

At a glance

Status

Active not recruiting

Sponsor

Boston University

Enrolment target

6,464

Start

01 Nov 2013

Estimated completion

01 Nov 2028

Bicuspid Aortic Valve Disease Thoracic Aortic Disease in Patients With a Bicuspid Aortic Valve

What is this study about?

Imagine your heart needing to pump blood out to your body through a big pipe called the aorta. At the start of this pipe, there's a valve, like a one-way door, called the aortic valve. Most people are born with an aortic valve that has three small flaps or leaflets, which open and close smoothly.

However, some people are born with a bicuspid aortic valve (BAV), meaning it only has two flaps instead of three. This is actually the most common heart problem people are born with. For many younger people, having a BAV doesn't cause any problems. But for others, especially as they get older, it can lead to issues. Sometimes, the main artery (aorta) can start to swell or weaken, or the valve itself might not work as well, either becoming stiff and narrow or not closing properly. This can eventually lead to the need for surgery to replace the valve.

The BAVCon study is a big international effort involving many hospitals and experts working together. The main goals are to understand why some people get a bicuspid aortic valve and what makes it worse over time. They are particularly interested in finding the genetic reasons behind BAV and its related problems like issues with the aorta. By gathering lots of information from patients with BAV, they hope to learn how to better predict who might develop problems and, in the future, find new and better ways to treat this condition.

Key takeaways

This is a big international study about bicuspid aortic valve (BAV) disease.
It aims to find the causes and better ways to predict and treat BAV.
Participation involves sharing medical information from your routine care, not extra tests.
There are no known risks because no new treatments are given.
Your ongoing medical care will not be affected if you join or withdraw.
The findings could benefit future patients with BAV.

Who may be eligible?

This study is looking for people who have already been diagnosed with a bicuspid aortic valve. This means your doctor has told you that your aortic valve has two flaps instead of the usual three.

To join, you need to be at least 8 years old. There's no upper age limit, so people up to 90 years old can take part. You also need to be able to fully understand and agree to participate in the study yourself, or for a younger person, a parent or guardian would need to agree and understand.

There are currently no specific reasons that would prevent someone who meets these basic criteria from joining the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a diagnosis of a bicuspid aortic valve?
Are you 8 years old or older?
Are you able to understand what it means to be in a study and give your permission (or can your parent/guardian)?
Are you receiving medical care at one of the participating hospitals?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will mainly collect information about your health as part of your regular medical appointments for your bicuspid aortic valve. This is an "observational" study, which means the researchers will be watching and recording what happens to you over time, but they won't tell you or your doctor how to treat your condition. Your medical care will continue as normal, decided between you and your healthcare team.

The study will gather details about your diagnosis, any treatments you receive, and how your health progresses. This information would come from your existing medical records and any new information collected during your routine clinic visits. There are no extra tests, medications, or specific clinic visits required just for the study. The total duration of your participation will depend on how long the study continues to follow patients, but it doesn't involve any additional time commitments beyond your usual medical care.

Potential risks and benefits

There are no anticipated risks involved in taking part in this study because it only involves collecting information from your medical records and during your routine appointments. You won't be given any new treatments or asked to undergo any extra procedures solely for the study. The potential benefit is that the information gathered from you and many other patients will help doctors and scientists better understand bicuspid aortic valve disease in the future, which could lead to better prediction and treatment for others. You are free to withdraw from the study at any time without affecting your medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Tufts Medical Center
Verified postcode
Boston, United States
Boston Medical Center
Verified postcode
Boston, United States
University of Michigan
Verified postcode
Ann Arbor, United States
Mayo Clinic
Verified postcode
Rochester, United States
University of Texas Health Science Center at Houston
Verified postcode
Houston, United States
Laval University
Verified postcode
Québec, Canada
Istituto Policlinico San Donato
Verified postcode
San Donato Milanese, Italy
Monaldi Hospital
Verified postcode
Naples, Italy
Second University of Naples
Verified postcode
Naples, Italy
University of Salerno
Verified postcode
Salerno, Italy
Hospital Vall d'Hebron
Verified postcode
Barcelona, Spain
University of Oxford
Verified postcode
Oxford, United Kingdom

Common questions

What is a bicuspid aortic valve?

It's when the main valve in your heart that lets blood out to your body has two flaps instead of the usual three.

Why is this study important?

It helps us understand why people get this condition, how it changes over time, and could lead to better ways to predict and treat it in the future.

Will I receive any new treatments in this study?

No, this study only collects information from your existing medical care; it doesn't involve giving new treatments or medications.

Who is running this study?

It's an international effort called BAVCon, involving many hospitals and experts from different countries.

Does this study involve any extra clinic visits for me?

No, your participation will be linked to your usual medical appointments and care for your bicuspid aortic valve.