RecruitingPHASE2INTERVENTIONAL

Impact of Local Tissue Inflammation on Intramyocardial Conduction Pathways Post Percutaneous Valve : Evaluation by Positron Emission Tomography on Exploratory Cohort

This study is investigating 'aortic valve stenosis,' a common condition where the heart's main valve narrows. We're focusing on patients who receive a new valve through a keyhole procedure called TAVI. While TAVI is very effective, some patients develop problems with their heart’s electrical signals afterwards, often needing a pacemaker. However, many pacemakers fitted aren't actually needed in the long run. We believe that inflammation in the heart muscle after the TAVI procedure might play a role in these electrical problems. Using a special type of scan called an 18F-FDG PET-CT, we hope to identify early signs of this inflammation. The goal is to better understand these heart signal issues and, importantly, to find ways to predict which patients truly need a pacemaker, helping to avoid unnecessary procedures and their associated risks.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University Hospital, Brest

Enrolment target

100

Start

23 Nov 2022

Estimated completion

23 Nov 2028

Aortic Valve Stenosis

What is this study about?

Imagine your heart has a very important door (the aortic valve) that helps blood flow out to your body. Sometimes this door gets stiff and narrow, a condition called aortic valve stenosis. This makes your heart work much harder. A common treatment is to replace this narrow valve with a new one using a procedure called TAVI (Transcatheter Aortic Valve Implantation). This is often done through a small tube inserted into a blood vessel, usually in your leg, which is less invasive than open-heart surgery.

While TAVI is a fantastic treatment that helps many people, a common side effect is that some patients develop problems with the heart's electrical system, which can cause it to beat irregularly. This sometimes means they need a pacemaker, a small device that helps the heart maintain a regular rhythm. However, we've noticed that not everyone who gets a pacemaker after TAVI actually relies on it. In fact, many might not need it in the long run.

This study aims to understand why these electrical problems happen and, crucially, if we can predict who will truly need a pacemaker. We think that swelling or inflammation in the heart muscle around where the new valve is placed might be a culprit. We’ll be using a special type of scan, called an 18F-FDG PET-CT scan, which can help us see areas of inflammation in the body. By looking for early signs of this inflammation after TAVI, we hope to find a way to identify patients who are more likely to develop electrical problems, ultimately helping to ensure that pacemakers are only fitted when absolutely necessary.

Key takeaways

This study investigates heart rhythm issues after a keyhole valve replacement (TAVI).
It uses a special scan (PET-CT) to look for inflammation in the heart.
The goal is to predict who truly needs a pacemaker, reducing unnecessary fittings.
Participation involves the standard TAVI procedure plus an additional heart scan.
No new medications are given as part of this study.

Who may be eligible?

To join this study, you need to be an adult over 18 years old and have a condition called aortic valve stenosis, which means your heart's main valve is narrowed. This narrowing should be diagnosed by a heart scan (echocardiogram) showing specific measurements that indicate severe narrowing. You also need to be experiencing symptoms like shortness of breath, or showing problems during an exercise test, or have a weak heart pump even if you don't feel symptoms.

Critically, your blood vessels must be suitable for the TAVI procedure – the keyhole heart valve replacement – usually meaning the arteries in your leg can accommodate the tubes used. You'll also need to be part of a health insurance scheme and be able to provide your full agreement (consent) to take part.

There are also some reasons why you wouldn't be able to join. For example, if you already have a pacemaker, or if your valve problem is due to a rare type of aortic valve (uni or bicuspid). You also can't take part if you have very severe heart pump weakness, other serious valve diseases, or if your blood vessels aren't suitable for the TAVI procedure. If you have another heart valve replacement already in place, are pregnant or breastfeeding, unable to give consent, or have a life expectancy of less than 12 months, you wouldn't be eligible.

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 an adult over 18 with a narrowed aortic heart valve?
Do you have symptoms like breathlessness or problems during exercise?
Are your leg blood vessels suitable for a keyhole valve procedure (TAVI)?
Do you *not* currently have a pacemaker or another heart valve replacement?
Are you able to agree to take part in the study in writing?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo the standard TAVI procedure to replace your aortic valve. The main extra part of the study involves having a special scan called an 18F-FDG PET-CT scan. This scan helps us look for inflammation in your heart. You'll also have regular follow-up appointments, as is standard after a TAVI procedure, where doctors will monitor your heart's electrical activity and overall health. We'll be looking at the results of your scans and monitoring to see if there's a link between inflammation and any changes in your heart's electrical system. The total duration of your participation in the study would be integrated within your existing medical care, focusing on the period after your TAVI.

Potential risks and benefits

Taking part in this study might help us better understand why some people need pacemakers after TAVI, potentially leading to better care for future patients. For you, the main benefit is contributing to medical knowledge. There are no additional direct medical treatments or interventions in this study beyond your standard TAVI care. The main extra risk involves the 18F-FDG PET-CT scan, which uses a small amount of a radioactive tracer and involves exposure to radiation, similar to other medical scans. There's also the time commitment for this additional scan. Remember, you can choose to leave the study at any time without it affecting your medical care.

Locations (1)

CHU de Brest
Verified postcode
Brest, France· Recruiting

Common questions

What is aortic valve stenosis?

It's a condition where the main valve in your heart (aortic valve) becomes narrow, making it harder for blood to flow out of your heart.

What is a TAVI procedure?

TAVI is a modern way to replace a narrowed aortic valve using a small tube inserted through a blood vessel, usually in your leg, rather than open-heart surgery.

Why is this study looking at pacemakers?

After TAVI, some patients need a pacemaker for heart rhythm problems. This study wants to find out if we can predict who truly needs one to avoid unnecessary procedures.

What is an 18F-FDG PET-CT scan?

It's a special scan that helps doctors see areas of inflammation or unusual activity in your body, in this case, in your heart muscle.

Will I get any new medicine for being in the study?

No, this study doesn't involve any new medicines. It's about using a special scan to understand what happens after a standard TAVI procedure.

How to find out more

Romain Didier, Dr

romain.didier@chu-brest.fr 298347392 Official trial record

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