Active not recruitingOBSERVATIONAL

ACURATE neo2™ Post Market Clinical Follow up Study

This study is gathering information about how well a new heart valve called ACURATE neo2 works in everyday medical practice. This valve is used to replace a narrowed or faulty aortic valve in the heart, a condition known as severe aortic valve stenosis. Doctors are observing patients who receive this new valve to see how they recover and how the valve performs over time. The main goal is to collect information on its safety and effectiveness in the real world. This helps ensure the device is working as expected for patients who need this important heart procedure. About 200 patients will be included, and they will be followed for several years.

At a glance

Status

Active not recruiting

Sponsor

Boston Scientific Corporation

Enrolment target

250

Start

16 Dec 2020

Estimated completion

31 Dec 2026

Aortic Valve Stenosis Aortic Valve Calcification Aortic Diseases

What is this study about?

Imagine your heart has a tiny door, called the aortic valve, that opens and closes to let blood flow out to your body. Sometimes, this door can become stiff and narrow, making it harder for blood to get through. This is called 'aortic valve stenosis' and it can make you feel breathless or tired.

Traditionally, a surgeon might open your chest to replace this valve. However, a newer, less invasive method called Transcatheter Aortic Valve Implantation (TAVI) allows doctors to insert a new valve using a small tube, often through a blood vessel in your leg. This study is specifically looking at a new type of TAVI valve called ACURATE neo2.

The ACURATE neo2 PMCF study is like a real-world check-up. It's designed to see how this new heart valve performs in patients during their regular treatment. It's not testing a new medicine, but rather observing how a commercially available device works for people in their daily lives. By collecting information from about 200 patients, doctors can learn more about how effective and safe this particular valve is over several years.

Key takeaways

This study observes a new type of heart valve called ACURATE neo2.
It aims to understand how the valve performs in real patients post-procedure.
Participation involves extra check-ups and scans for up to five years.
You are receiving a standard, approved treatment, not an experimental one.
Your participation helps improve care for future patients needing TAVI.
You can stop participating at any time without affecting your care.

Who may be eligible?

Generally, if your doctor believes the ACURATE neo2 heart valve is suitable for your treatment, you might be asked to join this study. There aren't many strict rules for who can join, as the study aims to see how the valve works for typical patients in normal medical care. The most important thing is that you and your doctor decide this particular valve is the right choice for you.

However, you wouldn't be able to join if you've already had a different replacement valve in your aortic position before. Also, if you have very severe kidney disease or a specific type of irregular heartbeat (atrial fibrillation) that can't be controlled, you might not be eligible. Another reason you couldn't participate is if you are expected to need long-term blood-thinning medication after your valve procedure.

Quick self-check

Am I being considered for the ACURATE neo2 valve for my aortic stenosis?
Have I had a previous replacement valve in my aortic position before?
Do I have very severe kidney disease?
Do I have an uncontrolled irregular heartbeat (atrial fibrillation)?
Will I need long-term blood-thinning medication after my procedure?

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 in this study, you'll first need to read and sign a consent form, which an independent committee has approved. This makes sure you understand what's involved. Once you agree, and the ACURATE neo2 valve system is used for your procedure, you're officially part of the study.

You'll have several check-ups after your procedure. There will be one before you leave the hospital, then another after 30 days, and then after one year. For the first year, these will be in-person visits. After that, you'll have yearly check-ups for up to five years. These later visits can be in-person or a phone call, whichever is easier. Additionally, you'll have special scans called 4D CTs at the 30-day and one-year marks to get a detailed look at the valve.

Potential risks and benefits

The main benefit of participating is helping medical science learn more about the ACURATE neo2 heart valve, which could improve care for future patients. Since this is an observational study of a device your doctor has already decided is right for you, the direct medical benefits are mainly from receiving the TAVI procedure itself. There are potential risks associated with any medical procedure, including TAVI, and your doctor will discuss these with you. Becoming part of a study means some extra appointments and scans, which might be inconvenient. Importantly, you are free to withdraw from the study at any time without it affecting your medical care.

Locations (19)

Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
Kerckhoff-Klinik GmbH Herz und Thorax Zentrum Abteilung Kardiologie/Kardiochirurgie
Bad Nauheim, Germany
HDZ Bad Oeynhausen
Bad Oeynhausen, Germany
St.-Johannes-Hospital
Dortmund, Germany
Universitätsklinik Regensburg
Regensburg, Germany
A.O.U Policlinico "G.Rodolico - San Marco"
Catania, Italy
San Raffaele Hospital
Milan, Italy
Azienda Ospedaliera Pisana
Pisa, Italy
Erasmus Medical Center
Rotterdam, Netherlands
UMC Utrecht
Utrecht, Netherlands

+7 more sites — see the official record for the full list.

Common questions

What is the ACURATE neo2 valve?

It's a type of replacement heart valve used in a less invasive procedure called TAVI to fix a narrowed aortic valve.

Why is this study being done?

The study aims to see how well the ACURATE neo2 valve performs and how safe it is for patients in real-world everyday use.

Will I get a new treatment?

No, this study observes patients who are already receiving the ACURATE neo2 valve as part of their standard medical care; it's not testing a new or experimental treatment.

How long will I be in the study?

You'll be followed for up to five years after your heart valve procedure, with regular check-ups.

What if I change my mind about participating?

You can withdraw from the study at any time, and it won't affect the medical care you receive.