RecruitingOBSERVATIONAL

Prospective Study of Lead-associated Tricuspid Regurgitation in Patients Undergoing New Transvalvular Lead Insertion

This study is investigating a heart condition called tricuspid valve regurgitation (TR) in people who are having a pacemaker or defibrillator fitted for the first time. The tricuspid valve is one of the heart's four valves, and regurgitation means the valve leaks. When a pacemaker or defibrillator is put in, it involves placing a thin wire (called a lead) through a vein and into the heart, passing through the tricuspid valve. Researchers want to see if this process causes new leaks in the tricuspid valve or makes existing ones worse. They will perform detailed heart scans before the procedure and then at 6 and 12 months afterwards to monitor any changes. This will help doctors understand more about how these common heart devices might affect the tricuspid valve over time.

At a glance

Status

Recruiting

Sponsor

Hazem Omran

Enrolment target

200

Start

19 Jul 2024

Estimated completion

30 Jan 2027

Tricuspid Valve Regurgitation Pacemaker ICD Left Bundle Branch Area Pacing

What is this study about?

This research study is looking into a topic called tricuspid valve regurgitation, often shortened to TR. The tricuspid valve is one of the four important valves in your heart, separating the upper and lower chambers on the right side. It works like a one-way door, making sure blood flows in the right direction. When this valve leaks, it's called regurgitation.

Many people need a pacemaker or an implantable cardioverter-defibrillator (ICD) – these are small electronic devices that help your heart beat regularly. To put these devices in, a thin wire, called a lead, is threaded through a vein and usually passes right through the tricuspid valve. Currently, we know that after these devices are fitted, some people develop a new leak in their tricuspid valve, or an existing leak might get worse. This study aims to understand exactly how often this happens and why, by carefully checking people before and after their device is implanted.

By taking part, you would help doctors learn more about how pacemakers and ICDs might affect the tricuspid valve. This information is really important because it could help doctors improve how they care for people having these devices in the future, ultimately leading to better health outcomes for many people.

Key takeaways

The study looks at how pacemakers or defibrillators might affect a heart valve called the tricuspid valve.
It checks if these devices cause new leaks or make existing leaks worse in the tricuspid valve.
Participation involves extra heart scans and blood tests over 12 months.
There are no new medicines or procedures beyond standard care for your device.
Your involvement helps improve future care for people with these heart devices.

Who may be eligible?

This study is looking for adults aged 18 or over who are about to have a pacemaker or a defibrillator (ICD or CRT device) fitted for the very first time. They need to be generally healthy apart from the heart condition that requires the device, and they shouldn't already have problems like a severe leaky tricuspid valve.

You wouldn't be able to join if you've already had one of these devices, or if you've had surgery on your tricuspid valve before. Also, if you have other severe heart valve problems, very high blood pressure in your lungs, or certain other heart conditions from birth or that affect the right side of your heart, you wouldn't be eligible. Individuals who are pregnant or breastfeeding, or who have a life expectancy of less than 12 months, also cannot participate.

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 a pacemaker or defibrillator fitted for the FIRST time?
Do you NOT have a severe leaky tricuspid valve already?
Do you NOT have other serious heart valve problems or severe lung blood pressure?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several visits over about a year. Before your pacemaker or defibrillator is put in, you'll have a detailed heart scan called an echocardiogram, which uses sound waves to create pictures of your heart, including a close look at your tricuspid valve. After your device is fitted, you'll come back for check-ups at 6 months and again at 12 months.

At these follow-up visits, you'll have another echocardiogram, an ECG (a simple test to check your heart's electrical activity), a blood test to measure a specific heart marker called NT-proBNP, and a routine check of your pacemaker or defibrillator. There are no new medications to take as part of this study, nor new procedures beyond what you'd normally receive for your device. The total duration of your active participation, including all follow-up appointments, would be approximately 12 months.

Potential risks and benefits

Taking part in this study could help future patients by providing valuable information about how pacemakers and defibrillators affect the heart over time. However, there are no direct health benefits for you personally from participating. The main risks are minor discomfort or bruising from blood tests, and the time commitment for the extra scans and visits. All scans and tests are standard procedures and are generally very safe. Remember, participating is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

Herz- und Diabeteszentrum NRW
Verified postcode
Bad Oeynhausen, Germany· Recruiting

Common questions

What is 'tricuspid regurgitation'?

It means one of the valves in your heart, the tricuspid valve, is leaking and not closing properly.

What is a 'pacemaker' or 'defibrillator'?

These are small devices placed in your body to help your heart beat normally if it's too slow or irregular.

Will I have to take new medicines?

No, this study doesn't involve any new medicines. You'll continue with your usual treatment as recommended by your doctor.

How long will I be involved in the study?

You'll be involved for about 12 months in total, with a few visits during that time.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Hazem Omran, MD

homran@hdz-nrw.de +49 5731 970 Official trial record

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