RecruitingOBSERVATIONAL

Abbott Structural Heart Device Registry

This study, called the Abbott Structural Heart Registry, is designed to check how well certain Abbott heart devices perform and how safe they are when used in routine hospital care across the UK and other countries. It's for people with various heart conditions, such as holes in the heart (like ASD, VSD, PFO) or issues with heart valves. The study gathers information from regular appointments and procedures that patients would have anyway. This helps prove that the devices already available for use are working as expected and meet important safety rules. Taking part means sharing your medical information from your standard care, with consent, to help improve understanding of these heart treatments for everyone.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

2,500

Start

21 Aug 2024

Estimated completion

01 Nov 2039

Heart Diseases ASD - Atrial Septal Defect VSD - Muscular Ventricular Septal Defect PFO - Patent Foramen Ovale PIVSD - Post Infarct Muscular Ventricular Septal Defect Valvular Heart Disease

What is this study about?

Imagine you have a heart condition that might need a special device, like one to close a hole in your heart or fix a valve. Once these devices are approved for use, it's really important to keep checking how well they work and if they are safe when used in everyday hospital settings, not just in special trials. That's exactly what the Abbott Structural Heart Registry aims to do. It collects information from patients who have already received, or are about to receive, one of these Abbott heart devices as part of their standard care.

The main goal is to make sure these devices continue to perform safely and effectively for people with heart problems in the real world. This information helps meet important regulations, like those in the European Union, which require ongoing checks on medical devices. By gathering data from many hospitals over several years, this registry helps confirm that the devices you or a loved one might receive are reliable and doing their job.

So, this isn't a study where you get a new, experimental treatment. Instead, it's about carefully watching how existing treatments work for people just like you, in regular hospital settings. This helps doctors and manufacturers continually improve treatment options and ensure high standards of care for heart patients.

Key takeaways

It checks how Abbott heart devices work safely in everyday hospital care.
Participation involves sharing information from your regular medical appointments.
It's for people having devices for conditions like heart holes or valve issues.
There are no extra medical procedures or treatments involved.
Your contribution helps improve understanding of heart device performance.
You can stop participating at any time without affecting your care.

Who may be eligible?

To be part of this study, you would either be about to have, or have recently had, an Abbott Structural Heart device fitted as part of your normal heart treatment. This could be a device for a condition like a hole in your heart (such as an ASD, VSD, or PFO) or a problem with your heart valves.

Importantly, you need to be willing to follow your usual hospital check-up schedule and agree to share your routine medical information for the study. If you've passed away, your family might be asked, if local rules allow, to contribute your information to the study, especially if your device was fitted some time ago. It's all about making sure the information gathered is useful and respects your privacy.

However, you can't join this study if you're already taking part in another medical study that might affect the results of this one. Otherwise, if you meet the main criteria and are happy to consent, you could be eligible, regardless of your age or gender.

Quick self-check

Have I recently had, or am I about to have, an Abbott heart device implanted?
Am I willing to go to my planned hospital follow-up appointments?
Am I happy for information from my regular care to be used for this study?
Am I not currently in another medical study that might interfere with this one?
Do I have one of the heart conditions mentioned (e.g., ASD, VSD, PFO, valve disease)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, it generally involves sharing information from your routine hospital visits and procedures where you receive an Abbott heart device. You wouldn't have any extra appointments or tests just for the study. The study team would collect data from your standard check-ups that would happen anyway, whether they are in person, over the phone, or online.

The length of time you're followed depends on the specific Abbott device you receive. For some devices, data will be collected at the time you leave the hospital, and then at 1-3 months, 6 months, and 12 months. For other devices, your progress might be followed for up to 10 years to see how the device performs over its lifetime. It’s all about using information from the care you already receive.

Potential risks and benefits

Taking part in this study doesn't come with additional medical risks because it only involves collecting information from the standard care you would receive anyway. You won't have different treatments or extra procedures. The potential benefit is that your information helps medical professionals and manufacturers better understand how these heart devices perform in the real world, leading to improved care for future patients. You have the right to withdraw your consent and stop participating at any time without it affecting your medical care.

Locations (28)

Robert Wood Johnson University Hospital
New Brunswick, United States· Not yet recruiting
Mount Sinai Hospital
New York, United States· Not yet recruiting
University of Pennsylvania
Philadelphia, United States· Not yet recruiting
UPMC
Pittsburgh, United States· Not yet recruiting
Sentara Norfolk General Hospital
Norfolk, United States· Not yet recruiting
Odense University Hospital
Odense, Denmark· Recruiting
Tartu University Hospital
Tartu, Estonia· Recruiting
CHRU Hopital de Pontchaillou
Rennes, France· Recruiting
Centre Médico Chirurgical Marie Lannelongue
Le Plessis-Robinson, France· Recruiting
Hopital Haut Leveque
Pessac, France· Recruiting
Deutsches Herzzentrum München des Freistaates Bayern
München, Germany· Recruiting
Klinikum Links der Weser
Bremen, Germany· Recruiting

+16 more sites — see the official record for the full list.

Common questions

Will I receive a new or experimental treatment in this study?

No, this study only collects information about Abbott heart devices that are already approved and used in routine hospital care. You will receive standard treatment.

Do I need extra doctor's appointments if I participate?

No, you do not need any extra appointments. The study uses information from your regular, planned check-ups with your doctor.

How long will I be involved in the study?

The length varies. For some devices, it's up to a year, but for others, it could be up to 10 years, aligning with your usual medical follow-ups.

Will my personal medical information be kept private?

Yes, strict rules are followed to protect your personal and medical information, just like in your regular hospital care.

Can I change my mind and stop participating?

Yes, you can withdraw from the study at any time without it affecting your medical care or relationship with your doctor.

How to find out more

Laetitia Beullens

laetitia.beullens@abbott.com +32 277 46 937 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.