Active not recruitingNAINTERVENTIONAL

Early Feasibility Study (EFS) of Abbott's Balloon-expandable (BE) TAVI System for the Treatment of Severe, Symptomatic Aortic Stenosis

This research is an early study looking into a new way to treat a serious heart condition called severe aortic stenosis. This condition happens when the main valve in your heart doesn't open properly, making it harder for your heart to pump blood around your body. The study is testing a new device from Abbott, which is a type of replacement valve that can be put in without major open-heart surgery, often called TAVI. The main goal is to find out if this new device is safe and if it works well in patients. Researchers will be carefully checking how the device performs and if it helps improve patients' health.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

Start

30 Oct 2025

Estimated completion

01 Jun 2031

Symptomatic Severe Aortic Stenosis

What is this study about?

This study is an early research project designed to test a new medical device for a heart condition called severe aortic stenosis. Imagine your heart has a main door (the aortic valve) that lets blood out to the rest of your body. In severe aortic stenosis, this door becomes stiff and narrow, making it very hard for your heart to push blood through. This can make you feel tired, breathless, or have chest pain.

The new device being tested is called the Abbott BE TAVI System. TAVI stands for Transcatheter Aortic Valve Implantation, which is a way to replace the faulty heart valve using a thin tube (catheter) inserted into a blood vessel, usually in the leg, rather than requiring open-heart surgery. This early study is focusing on checking the safety of this new system and how well it works once it's in place.

The information gathered from this study will be crucial in understanding if this new Abbott device is a good and safe option for people with severe aortic stenosis. It's a first step in seeing if it could potentially help many patients in the future who need their aortic valve replaced.

Key takeaways

This study is for a new way to replace a heart valve without open-heart surgery.
It's an early study, mainly checking if the new device is safe and effective.
It's for people with severe aortic stenosis.
You must be at least 18 and able to attend follow-up visits.
Participation involves receiving the new device and regular check-ups.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have a specific severe narrowing of your heart's main valve (aortic stenosis), which is causing symptoms. This condition must be confirmed by heart scans.

You also need to be able and willing to come to all the necessary follow-up appointments and checks. This is very important so the study team can properly monitor your health and how the device is working over time.

There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or if you have another significant illness that means you are not expected to live for at least two more years. People with certain serious heart problems like a recent heart attack, untreated blockages in their heart arteries, severe liver failure, or other major heart valve issues would also not be able to take part. The study also cannot include individuals who are severely incapacitated.

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?
Do you have severe aortic valve narrowing that causes symptoms?
Can you attend all necessary follow-up appointments?
Are you NOT currently pregnant or breastfeeding?
Have you NOT recently had a heart attack or have untreated major heart artery blockages?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the Abbott BE TAVI System as your treatment for severe aortic stenosis. Following the procedure, you will need to attend several follow-up visits with the study team. These visits will involve various tests and assessments, such as heart scans and blood tests, to check how you are recovering and how the new valve is working. The study team will explain the full schedule of visits and what each will involve. You will also be asked about your general health and any symptoms you might have. The total duration of your participation in this study, including all follow-up appointments, will be explained by the study team, but it's important to be prepared for regular checks over a period of time.

Potential risks and benefits

Participating in this study might offer you access to a new, potentially less invasive heart valve treatment that could improve your symptoms and quality of life. However, as with any medical procedure, there are potential risks, including those associated with heart valve replacement and the specific TAVI procedure, such as bleeding, infection, and complications related to the device. The study is designed to carefully monitor safety, but not all potential benefits are guaranteed, and not all risks are fully known at this early stage. You have the right to withdraw from the study at any time without affecting your standard medical care.

Locations (5)

Via Christi Regional Medical Center
Verified postcode
Wichita, United States
Abbott Northwestern Hospital
Verified postcode
Minneapolis, United States
Columbia University Medical Center/New York-Presbyterian
Verified postcode
New York, United States
Montefiore Medical Center - Moses Division
Verified postcode
The Bronx, United States
Clinique Pasteur Toulouse
Verified postcode
Toulouse, France

Common questions

What is 'aortic stenosis'?

Aortic stenosis is a heart condition where the main valve in your heart, which lets blood flow out to your body, becomes stiff and narrow. This makes your heart work harder.

What does 'TAVI system' mean?

TAVI (Transcatheter Aortic Valve Implantation) is a way to replace a faulty heart valve using a thin tube inserted through a blood vessel, usually in your leg, rather than opening your chest with surgery.

Is this a new treatment?

Yes, this is an 'early feasibility study' for Abbott's new TAVI system, meaning it's one of the first times it's being tested in people to check its safety and how it works.

How long would I be in the study?

The study team will tell you the full timeline, but it involves the procedure and regular follow-up visits over a period of time to check your progress.

Will I get this new device even if I don't join the study?

Currently, this specific Abbott device is only available to patients participating in this research study because it's still being evaluated.