RecruitingNAINTERVENTIONAL

REpeat Intervention For Failed Surgical BioProsthEtic AorTic Valves (REPEAT)

This study, called REPEAT, is looking at the best way to treat people whose artificial heart valve, put in during a previous surgery, has started to fail. When an artificial aortic valve wears out, doctors need to replace it. This trial compares two main options: having another open-heart surgery to replace the valve (redo surgical replacement), or a less invasive procedure called a valve-in-valve implantation. In valve-in-valve, a new artificial valve is carefully guided through a blood vessel, usually in the leg, and placed inside the old, failing one. The main goal is to see which treatment leads to better long-term health over five years. Researchers will be tracking important outcomes like whether people stay alive, have a stroke or heart attack, need to go back to hospital for heart problems, or need another heart valve procedure.

At a glance

Status

Recruiting

Phase

Sponsor

Heart Center Leipzig - University Hospital

Enrolment target

890

Start

10 Nov 2025

Estimated completion

30 Sep 2033

Degenerative Aortic Valve Disease

What is this study about?

Imagine your heart has a special door, called the aortic valve, that opens and closes to let blood flow out to your body. Sometimes, this door can become worn out or damaged, and doctors might replace it with an artificial one during open-heart surgery. However, these artificial doors don’t last forever, and sometimes they need to be replaced again.

This important study, called the REPEAT trial, is looking at the best way to handle this situation when an artificial aortic valve that was put in during a previous surgery starts to fail. There are two main ways doctors can fix this: either by doing another open-heart surgery to replace the valve (this is called redo surgical aortic valve replacement), or by using a newer, less invasive method. This newer method is called valve-in-valve transcatheter aortic valve replacement (ViV-TAVR). In ViV-TAVR, a new valve is delivered through a small tube in a blood vessel, typically in the leg, and placed inside the old, failing artificial valve, without needing a big operation.

The main question this study wants to answer is, which of these two approaches is better for patients in the long run? The researchers will be carefully observing people over five years to see which treatment leads to fewer serious problems like death, stroke, heart attack, needing to go back to hospital for heart failure, or needing another heart valve procedure. By comparing these outcomes, the study aims to help doctors and patients make the most informed decision about the best treatment option.

Key takeaways

Compares two ways to fix a failing artificial heart valve: open-heart surgery vs. valve-in-valve procedure.
Aims to find out which treatment is better for long-term health over five years.
Looks at serious outcomes like death, stroke, heart attack, and rehospitalisation.
Participants must have a failing artificial aortic valve and be between 18 and 75 years old.
Requires a medical team to agree that both options are suitable for the patient.

Who may be eligible?

To be able to join this study, you would generally need to have an artificial aortic heart valve that was put in during a previous surgery, and that valve has now started to fail. Doctors would need to agree that both another open-heart surgery and the valve-in-valve procedure are safe and reasonable options for you. You would also need to be between 18 and 75 years old.

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 have an artificial aortic heart valve that doctors say is failing?
Are you generally in good health otherwise and considered low to intermediate risk for surgery?
Are you between 18 and 75 years old?
Has your Heart Team (a group of expert doctors) said that both open-heart surgery and valve-in-valve are reasonable options for you?
Do you not currently have major issues like multiple valve diseases or severe blockages in your heart arteries that cannot be fixed?

Answer every question to see your result.

What does participation involve?

The detailed plan for taking part in this study isn't fully described here, but generally, if you join, you would be assigned to receive either the second open-heart surgery or the valve-in-valve procedure. You would have regular check-ups and tests over a period of five years to see how you are doing. This would involve visits to the hospital or clinic, and assessments to monitor your heart health and overall well-being. The study would keep track of any major health events like heart attacks, strokes, or further hospital stays related to your heart.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as receiving state-of-the-art care and close monitoring of your health. However, there are also potential risks associated with any medical procedure, including the possibility of complications from either the open-heart surgery or the valve-in-valve procedure. The study aims to understand which approach is safer and more effective. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (1)

Herzzentrum Leipzig GmbH
Verified postcode
Leipzig, Germany· Recruiting

Common questions

What does 'failed surgical bioprosthetic aortic valve' mean?

It means an artificial heart valve that was put in during a previous surgery is no longer working as well as it should, either because it's too narrow or it's leaking.

What is the difference between the two treatments being compared?

One is another open-heart surgery to replace the faulty valve, and the other is a less invasive procedure where a new valve is put inside the old one using a tube in your blood vessel.

How long will the study follow participants?

The study plans to follow people for five years after their procedure to see how well they are doing long-term.

Will I have a choice of which treatment I get?

This study will assign you to one of the treatments. Your medical team will consider what's safest and most suitable for you when discussing your options.

What kind of problems are researchers looking for?

They're looking for serious health issues like dying from any cause, having a stroke or heart attack, needing to go back to hospital for heart problems, or needing another heart procedure.

How to find out more

Michael Borger

michael.borger@helios-gesundheit.de 03418650 Official trial record

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