Active not recruitingOBSERVATIONAL

SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy

This study is an important way to learn about a specific mechanical heart valve called the SJM Masters HP 15mm. It's designed for children who need their aortic heart valve replaced because it's not working properly. Instead of testing a new treatment, this study carefully watches children who have already received or will receive this particular valve. The main goal is to understand how safe and effective this small valve is over many years. This information helps doctors better understand the best ways to care for children with aortic valve disease, ensuring they get the best possible treatment.

At a glance

Status

Active not recruiting

Sponsor

Abbott Medical Devices

Enrolment target

Start

24 Oct 2019

Estimated completion

01 Oct 2028

Aortic Valve Disease

What is this study about?

When your heart beats, valves open and close to keep blood flowing in the right direction. The aortic valve is one of these important valves. If it's not working correctly, it can cause problems for your heart. Sometimes, a faulty aortic valve needs to be replaced with a new one. This study is about a particular type of replacement valve called the SJM Masters HP 15mm mechanical heart valve, which is very small and often used for children.

This isn't a study where doctors are trying out a brand-new, untested treatment. Instead, it's a way to closely observe children who either have already received this specific 15mm mechanical heart valve or will be getting it as part of their regular medical care. The researchers are looking at information over a long time to see how well the valve works and if there are any issues.

The main aim is to understand the long-term safety and how effective this small valve is in children with aortic valve disease. By collecting detailed information from many children over time, doctors can gain valuable insights into the valve's performance. This helps medical professionals make the best decisions when caring for children who need an aortic valve replacement.

Key takeaways

This study observes a tiny mechanical heart valve (15mm) for children.
It aims to understand the valve's long-term safety and how well it works.
Participation involves receiving the valve and attending regular follow-up checks.
The information gathered helps doctors care for children with aortic valve disease.
It's an observational study, not testing a new, untried drug or device.

Who may be eligible?

This study is for children (of any age) who need an aortic heart valve replacement and whose doctor plans to use the SJM Masters HP 15mm mechanical heart valve. For a child to join, their parent or legal guardian must agree in writing to let them take part and follow the study's plan. This means attending appointments and completing necessary checks throughout the study period.

Children who have already received this specific 15mm valve might also be able to join. This is to gather information about how the valve works in real life. If a child has already had the implant, their legal guardian would need to agree to share their past medical information and participate in future check-ups, if applicable.

There are also specific reasons why someone might not be able to join, called 'exclusion criteria.' These would be discussed with you by the study team to make sure the study is right for your child. In simple terms, if a child has a medical condition or situation that makes it unsuitable or unsafe for them to participate, they wouldn't be able to join.

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.

Is your child needing an aortic valve replacement?
Does your doctor plan to use the SJM Masters HP 15mm mechanical heart valve?
Are you, as the parent/guardian, willing to give written permission for your child to join?
Are you, as the parent/guardian, able to commit to follow-up appointments and assessments?
Has your child already had this specific 15mm valve implanted and you're willing to share past medical records and attend future checks (if applicable)?

Answer every question to see your result.

What does participation involve?

If your child joins this study, they will receive the SJM Masters HP 15mm mechanical heart valve as part of their planned aortic valve replacement surgery. You and your child will then follow a specific schedule of follow-up appointments and assessments. These appointments are designed to check your child's health and how the new heart valve is performing over time. This might involve scans like echocardiograms (heart ultrasounds) and other routine medical checks.

The study team will clearly explain the exact schedule of visits and what each visit will involve. They will also tell you how long your child is expected to be part of the study. There may be forms to fill in and questions to answer at these appointments. All these checks are part of ensuring the safety and effectiveness of the valve are well understood.

Potential risks and benefits

Taking part in this study means your child will receive the SJM Masters HP 15mm mechanical heart valve, which is a standard treatment option. The potential benefit is that by carefully monitoring your child's progress, the medical community will learn more about this specific valve, which can help other children in the future. As with any medical procedure, there are potential risks associated with heart valve replacement surgery itself, and specific risks linked to mechanical valves, which your doctor will discuss thoroughly. You have the right to withdraw your child from the study at any time, even if you’ve initially agreed for them to take part. This will not affect their medical care.

Locations (13)

Children's Hospital Los Angeles (USC)
Verified postcode
Los Angeles, United States
Valley Children's Hospital
Verified postcode
Madera, United States
Sutter Medical Center, Sacramento
Verified postcode
Sacramento, United States
Variety Children's Hospital
Verified postcode
Miami, United States
Children's Healthcare of Atlanta
Verified postcode
Atlanta, United States
University of Mississippi Medical Center
Verified postcode
Jackson, United States
Cincinnati Children's Hospital
Verified postcode
Cincinnati, United States
Dell Children's Medical Center
Verified postcode
Austin, United States
Children's Medical Center Dallas
Verified postcode
Dallas, United States
Sana - Herzchirurgische Klinik Stuttgart GmbH
Verified postcode
Stuttgart, Germany
Deutsches Herzzentrum München des Freistaates Bayern
Verified postcode
München, Germany
Herzzentrum Leipzig GmbH
Verified postcode
Leipzig, Germany

Common questions

What is an aortic valve?

The aortic valve is one of the four main heart valves that helps blood flow from your heart to the rest of your body.

What does 'mechanical heart valve' mean?

A mechanical heart valve is an artificial valve made from strong materials that replaces a faulty heart valve.

Is this a new type of treatment?

The study is looking at a specific small mechanical heart valve (15mm) that is already used. It's not testing a completely new treatment.

How long will my child be in the study?

The exact duration will depend on the study plan, which the research team will explain to you in detail.

Will my child's treatment be different if they join?

Your child will receive the specific 15mm heart valve as planned, and the study involves closely monitoring their health and the valve's performance over time.