RecruitingOBSERVATIONAL

Pacemaker Implantation Following Transcatheter Tricuspid Valve Replacement

This research is investigating the best way to use pacemakers in patients who have received a new tricuspid heart valve through a procedure called transcatheter tricuspid valve replacement (TTVR). Sometimes, after this valve replacement, people can develop a condition where their heart's electrical signals don't work properly, leading to a very slow or irregular heartbeat. This often requires a pacemaker to help regulate it. This study aims to understand when it's best to put in a pacemaker for these patients and what the most effective approach is. They want to make sure patients get the best care to keep their heart healthy after their new valve.

At a glance

Status

Recruiting

Sponsor

Deutsches Herzzentrum Muenchen

Enrolment target

Start

01 Jan 2024

Estimated completion

31 Jan 2025

AV Block Complete Tricuspid Regurgitation (TR)

What is this study about?

When you have a tricuspid heart valve replaced using a special keyhole method (called transcatheter tricuspid valve replacement or TTVR), it can sometimes affect the electrical system of your heart. This electrical system is what controls your heartbeat, telling it when to beat and how fast. If this system gets disrupted, your heart might beat too slowly or irregularly.

This disruption is known as a 'heart block,' and in severe cases, it's called a 'third-degree atrioventricular block' (AVB). When this happens, a small device called a pacemaker is often needed. A pacemaker sends electrical pulses to your heart to help it beat at a normal and regular speed, making you feel much better.

However, doctors aren't yet completely sure about the very best time or way to put in a pacemaker after a TTVR procedure. This study aims to gather information to help doctors understand the most effective approach to pacemaker treatment for patients who have had this heart valve replacement. The goal is to improve care and make sure patients have the best chance of a healthy heart rhythm afterward.

Key takeaways

Looks at the best way to manage pacemakers after tricuspid heart valve replacement.
Aims to improve care for patients who might need a pacemaker after this procedure.
Focuses on understanding heart block, a common issue after certain heart valve operations.
Involves patients who have already had a transcatheter tricuspid valve replacement.
Suitable for all adults, regardless of age or gender.

Who may be eligible?

This study is looking for patients who have recently had a tricuspid heart valve replacement using a keyhole procedure called transcatheter tricuspid valve replacement (TTVR). Both men and women of all ages can take part.

There are no specific reasons that would prevent someone from joining this study. Generally, if you've had this particular heart valve procedure, you might be suitable.

The research team will carefully check your medical history to make sure the study is a good fit for you.

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.

Have you had a tricuspid heart valve replaced using a keyhole (transcatheter) method?
Are you an adult (any age)?
Are you male or female?

Answer every question to see your result.

What does participation involve?

The information provided does not detail what taking part in this study would involve, such as specific visits, tests, or how long it would last. This type of study usually involves reviewing existing medical records of patients who have already had the procedure and, in some cases, following up with them over time. If you qualify and are interested, the study team would give you full details about any appointments, assessments, or follow-up that might be needed, and how long your involvement would be.

Potential risks and benefits

This study is gathering information to help improve care, so it may not directly benefit you personally. However, it could lead to better pacemaker management for future patients. As the study likely involves reviewing medical records or monitoring existing care, the immediate risks are generally low. However, all medical procedures and research carry some potential risks, which would be fully explained before you agree to take part. Remember, you can decide to stop participating at any time.

Locations (1)

Deutsches Herzzentrum München
Verified postcode
München, Germany· Recruiting

Common questions

What is a tricuspid heart valve?

It's one of the four valves in your heart that helps control blood flow between your heart's chambers.

What does 'transcatheter replacement' mean?

It's a way to replace a heart valve using a thin tube (catheter) inserted through a blood vessel, rather than open-heart surgery.

What is a pacemaker?

It's a small device implanted in your chest that sends electrical signals to your heart to help it beat regularly.

What is 'heart block'?

It's when the electrical signals that make your heart beat correctly are slowed down or blocked, causing an irregular or slow heartbeat.

Will I get a new treatment in this study?

This study is more about understanding the best use of pacemakers after a procedure you've already had, rather than testing a new treatment.

How to find out more

Carsten Lennerz, PD Dr. med.

lennerz@dhm.mhn.de 0049 89 1218 4401 Official trial record

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