RecruitingOBSERVATIONAL

Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study

This study is checking how safe and effective certain Abbott medical devices are after they've been used in surgery. These devices, called annuloplasty rings and bands, are used to help repair leaky heart valves, specifically the mitral and tricuspid valves. If you have a condition called 'mitral regurgitation' or 'tricuspid regurgitation', it means these valves aren't closing properly. The study involves people who are having surgery to fix their leaky valve using one of these Abbott devices. After their operation, they'll have yearly check-ups for five years. This helps doctors keep an eye on how well the devices are working and if there are any problems, making sure they meet European safety standards.

At a glance

Status

Recruiting

Sponsor

Abbott Medical Devices

Enrolment target

550

Start

01 Feb 2021

Estimated completion

01 Mar 2031

Mitral Regurgitation Tricuspid Regurgitation Valvular Heart Disease

What is this study about?

Imagine your heart has doors (valves) that open and close to let blood flow through. Sometimes, these doors don't close perfectly, causing blood to leak backward. This is called 'regurgitation', and it can happen in valves like the mitral and tricuspid valves. To fix this, surgeons can use special rings or bands, called 'annuloplasty devices', to help reshape and support the faulty valve so it closes better.

This study, officially called the 'Annuloplasty Rings and Band Post-Market Clinical Follow-Up Study', is designed to keep a close watch on how these specific Abbott-made rings and bands perform after they've been used in heart valve repair surgery. It's an important step because it helps ensure that these devices are safe and continue to work well for patients over time. It's like checking up on a new car model after it's been sold to make sure it's meeting all safety and performance expectations.

The study will follow people who have had one of these Abbott annuloplasty devices implanted during their heart surgery. They will be checked regularly for five years to see how they are recovering, how their heart is functioning, and if the device is doing its job as expected. This information is then used to meet important safety requirements in Europe.

Key takeaways

It's an observational study, meaning doctors are just watching how things go, not trying new treatments.
It checks the long-term safety and performance of specific Abbott heart valve devices.
Participation involves yearly check-ups for five years after your heart surgery.
This helps ensure medical devices are safe and effective for people with leaky heart valves.
You would be getting the same surgery and device whether or not you join the study.

Who may be eligible?

To join this study, you would need to be an adult, at least 18 years old. You should be planning to have heart surgery within the next 90 days (about 3 months) that will include one of the specific Abbott annuloplasty rings or bands used to fix either a leaky mitral or tricuspid valve.

It's also important that your surgery is performed by one of the doctors involved in this study. You’ll also need to be able to understand and sign a consent form, agreeing to all the study visits and procedures.

You wouldn't be able to join if you're under 18, or if you can't read or write, or have a mental health condition that would stop you from giving proper consent. You also can't have an active heart infection (endocarditis) at the time of your surgery, or be taking part in another medical study that involves treatments outside of normal care.

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.

Are you 18 years old or older?
Are you having surgery for a leaky mitral or tricuspid valve within the next 3 months?
Will your surgeon be using an Abbott annuloplasty ring or band?
Are you able to understand and sign a consent form for the study?
Do you feel you can attend yearly check-ups for five years?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be enrolled before your planned heart surgery where one of the Abbott annuloplasty devices will be implanted. After your surgery, you will have follow-up visits once a year for five years. These visits can either be in person at the clinic or over the phone.

During these visits, healthcare professionals will check on your overall health. They will ask about any new symptoms or problems, track any heart medications you might be taking, and assess how well your heart is working. They'll also use ultrasound scans of your heart (echocardiograms) to see how well the repaired valve is working and if there's any continued leakage. The total duration of your participation will be five years from the time of your surgery.

Potential risks and benefits

Participating in this study won't change your medical treatment, as you would be having the surgery and device implant regardless. The main benefit is helping doctors gather more information about how these devices work in real-world patients over the long term, which contributes to the safety and improvement of future patient care. There are no additional medical risks from being in the study beyond those typically associated with your planned heart surgery and recovery. Your privacy will be protected. You are free to withdraw from the study at any time without affecting your medical care.

Locations (17)

Duke University Hospital
Verified postcode
Durham, United States· Withdrawn
University of Wisconsin Hospital and Clinics
Verified postcode
Madison, United States· Withdrawn
Tartu University Hospital
Verified postcode
Tartu, Estonia· Recruiting
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Verified postcode
Lyon, France· Recruiting
CHU de Besançon - Jean Minjoz
Verified postcode
Besançon, France· Recruiting
Herzchirurgische Abteilung Klinikum Passau
Verified postcode
Passau, Germany· Recruiting
Universitätsklinikum Würzburg
Verified postcode
Würzburg, Germany· Completed
Herzzentrum-Bremen Klinikum Links der Weser
Verified postcode
Bremen, Germany· Recruiting
Herzzentrum Dresden, Universitätsklinik an der Technischen Universität Dresden
Verified postcode
Dresden, Germany· Recruiting
Universitätsklinikum Jena
Verified postcode
Jena, Germany· Recruiting
Policlinico S.Orsola-Malpighi
Verified postcode
Bologna, Italy· Recruiting
Ospedale San Raffaele - Cardiac
Verified postcode
Milan, Italy· Recruiting

Common questions

What kind of heart problems is this study looking at?

This study focuses on 'mitral regurgitation' and 'tricuspid regurgitation', which means certain heart valves aren't closing properly, causing blood to leak.

What are annuloplasty rings and bands?

They are special medical devices used in heart surgery to reshape and support a leaky heart valve, helping it close properly.

How long will I be in the study if I participate?

You will be followed for five years after your heart valve repair surgery.

Will I get different treatment if I join this study?

No, your medical treatment, including your surgery and the device used, will be the same whether or not you join the study.

Who is running this study?

This study is being conducted by Abbott, a medical device company, to meet European safety and performance requirements for their devices.

How to find out more

Karine Miquel

karine.miquel@abbott.com +32 479 60 01 07 Official trial record

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