RecruitingNAINTERVENTIONAL

Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE)

This study, called PLACE, is looking into how best to put in a pacemaker, which is a small device surgically inserted to help your heart beat properly. Sometimes, when a pacemaker wire (called a lead) is put into the heart, it can cause a problem with one of your heart valves, called the tricuspid valve. This can lead to a condition called tricuspid regurgitation, where the valve doesn't close properly. Researchers want to see if using a special type of ultrasound scan called transesophageal echocardiography (TEE) to guide the lead placement, in addition to the standard X-ray guidance, can help prevent this problem. They are comparing this new approach with the usual method to find out if it's better at keeping the tricuspid valve working well. Patients taking part will be followed for up to three years.

At a glance

Status

Recruiting

Phase

Sponsor

LMU Klinikum

Enrolment target

324

Start

01 Oct 2022

Estimated completion

01 Oct 2027

Tricuspid Regurgitation Pacemaker Complication

What is this study about?

Pacemakers are fantastic devices that can save lives and greatly improve the quality of life for many people whose hearts don't beat regularly. They work by sending small electrical pulses to the heart through thin wires, called leads, which are carefully placed inside your heart.

However, sometimes, when these leads are put into the heart's right lower chamber, they can rub against or press on one of the heart's valves, called the tricuspid valve. If this happens, it can stop the valve from closing properly. This problem is called tricuspid regurgitation. While often mild, severe tricuspid regurgitation can sometimes lead to issues like breathlessness and needing hospital care for heart failure, and it can affect your overall health.

Doctors are always looking for ways to make medical procedures safer and reduce potential problems. This study is testing whether using an additional type of ultrasound, called transesophageal echocardiography (TEE), during the pacemaker implantation procedure can help doctors place the lead more precisely. TEE involves a small probe passed down the food pipe which gives very clear pictures of your heart, helping the surgeon guide the lead. The aim is to see if this extra guidance can help prevent or reduce tricuspid regurgitation compared to the standard method that just uses X-ray guidance.

Key takeaways

This study investigates a new way to place pacemaker wires.
It aims to reduce a heart valve problem called tricuspid regurgitation.
Compares standard X-ray guidance with added special ultrasound (TEE) guidance.
Participants will be followed for up to 3 years.
Helps improve pacemaker safety for future patients.

Who may be eligible?

To be able to take part in this study, you would need to be an adult (18 years or older) and your doctor must have decided that you need a pacemaker lead put into the right side of your heart according to current medical guidelines. The study is open to both men and women.

However, there are some reasons why you might not be able to join. For example, if you already have a moderate or severe problem with your tricuspid valve (tricuspid regurgitation Grade 2 or higher), or if you've had surgery or treatment on this valve before. Also, if you have other serious heart valve problems or already have a pacemaker lead in place, you wouldn't be able to participate.

Lastly, if you're on long-term kidney dialysis or if there's a medical reason why you can't have the special ultrasound scan (transesophageal echocardiography), you wouldn't be able to join this particular study.

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.

Do you need a new pacemaker lead in your heart?
Are you 18 years old or older?
Do you NOT already have a moderate or severe problem with your tricuspid valve?
Have you NOT had surgery on your tricuspid valve before?
Are you NOT on long-term kidney dialysis?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be put into one of two groups by chance, like flipping a coin. One group will have their pacemaker lead put in using the standard X-ray guidance. The other group will also have X-ray guidance, but with extra help from the special ultrasound (TEE).

Both groups will have the pacemaker fitted as planned. After the procedure, the study team will keep in touch with you for up to three years. This will involve regular check-ups, which will include heart scans (echocardiograms) to see how your tricuspid valve is working. The doctors looking at these scans won't know which group you were in, to make sure the results are fair. You'll continue with your usual follow-up care for your pacemaker during this time.

Potential risks and benefits

Taking part in this study could potentially benefit you by helping doctors find a way to make pacemaker implantation even safer, reducing the risk of tricuspid valve problems. Even if your procedure goes ahead with the standard approach, you'll be helping medical science and future patients. As with any medical procedure, there are always some risks involved, even with the standard pacemaker implant. The extra ultrasound (TEE) also has its own small risks, which your doctor will discuss with you. You are free to withdraw from the study at any time without affecting your medical care.

Locations (1)

LMU Klinikum
Verified postcode
Munich, Germany· Recruiting

Common questions

What is a pacemaker lead?

A pacemaker lead is a thin wire that carries electrical signals from the pacemaker device to your heart, helping it beat regularly.

What is tricuspid regurgitation?

It's when the tricuspid valve in your heart doesn't close properly, causing some blood to flow backwards, which can sometimes lead to symptoms.

What is transesophageal echocardiography (TEE)?

It's a special ultrasound scan where a small probe is passed down your food pipe to get very clear pictures of your heart, helping doctors see it better.

How long will I be followed in the study?

You will be followed by the study team for up to three years after your pacemaker implantation.

Will I get to choose which treatment I receive?

No, you will be randomly assigned to one of the two groups, like drawing lots, to ensure fairness and good research results.

How to find out more

Daniel Braun, MD

daniel.braun@med.uni-muenchen.de +4989440072371 Official trial record

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