top of page

The REPEAT Trial Studies Life-Saving Treatment Strategies for Worn-Out Artificial Heart Valves

If you or your institution wants to join the REPEAT research group or enroll patients, please contact the medical project management using the link below.

The REPEAT Trial

REPEAT is an international randomized clinical trial, initiated and led by experts on heart diseases. It attempts to identify the best treatment for worn-out surgical aortic bioprostheses. Right now there is not a clear answer about what the best treatment for those failed bioprostheses is. The trial studies the long-term safety and efficacy of 2 options:

(1) A second open-heart surgery to replace the deteriorated bioprosthesis; or

(2) The implantation of a prosthesis mounted to a catheter and placed into the deteriorated bioprosthesis using vessels in the groin.

The trial is conducted by an international group of experts in cardiovascular medicine, and supported by peer-reviewed, public funding agencies in Germany and the United Kingdom. This trial will answer which of the above two options is the best treatment strategy for future patients to best increase the longevity and quality of life for thousands of people.

If you or somebody you know underwent open-heart surgery to replace  a diseased aortic valve using a bioprosthesis that does not work anymore, you could be eligible to participate in the trial. 

If you or your institution wants to join the REPEAT research group or enroll patients, please contact us.

We are looking for individuals and non-profit institutions who want to support the trial.

Support the Trial

This explains persuasively how important the trial is, the impact that it could have and that we are looking actively for individuals, institutions or companies wanting to support this very important and impactful research.

Cardiac Ultrasound
Doctor examining a patient's chest using a stethoscope

The results of The REPEAT Trial will improve the longevity and quality of life for thousands of people. 
 

Multidisciplinary teams of heart valve experts will discuss every candidate before offering to participate in the study.

1

Inclusion Criteria

  1. Age 19-74ys

  2. History of open heart surgery for aortic valve disease using a bioprosthetic heart valve

  3. Bioprosthetic deterioration due to narrowing and/or leakage requiring intervention

a doctor studying a checklist with a 65 years old male patient.jpg

2

Exclusion Criteria

  1. Prior mechanical or transcatheter aortic valve replacement

  2. Heart valve infection

  3. Requirement for additional procedures (e.g., other heart valve problems or coronary artery intervention)

a doctor explaining to a paient why he cannot enroll in a trial

3

Study Protocol following Randomization

  1. Baseline assessment using routine blood work, echocardiography, computed tomography, questionnaires, exercise capacity testing;

  2. Open surgery or stent-valve implantation based on standard of care protocols;

  3. Discharge assessment;

  4. Annual follow-up examinations until 5 years post-procedure

a doctor analyzing a cardiac ultrasound

What We Stand For

Scientific Integrity, Medical Excellence, and Humanitarian Service.

For many patients and their heart teams, the question about how to handle their deteriorated artificial heart valve is answered based on experience, not evidence. Even highly trained professionals have to rely on incomplete data to judge what to recommend in any given case. The REPEAT trial is the first and only randomized trial to meticulously study this pressing clinical challenge, to identify the best treatment of worn-out artificial heart valves.

The individuals behind the trial are experts in cardiovascular medicine and clinical trial design. The funding of the trial has been acquired exclusively through competitive public sources in order to facilitate the highest levels of scientific integrity.

The ultimate goal of this project is to answer the question on how to effectively treat worn-out aortic bioprostheses and thereby improve the life and longevity of countless individuals in the future.

grandparent is active and runs with his daughter and grandson

The REPEAT Trial in Numbers

Severely narrowed aortic valves are the most commonly treated heart valves. Nearly 50 of 100,000 individuals are affected per year. Valve replacement is the only effective intervention, and 4 out of 5 patients receive bioprosthetic valve replacement if open heart surgery is performed. These prostheses wear out over time, possibly requiring another intervention. For these patients, 2 options are available: (1) a second open-heart surgery or (2) a catheter-based valve implantation. Open-heart surgery has been the gold-standard for years, but many clinicians and patients try to avoid it because re-opening the chest is a traumatic event. For this reason, the number of catheter-based valve implantation to restore aortic valve function has grown exponentially in the past decade. It is less invasive, with shorter hospital stays, allowing patients to return to their lives quicker and easier. The procedure has become so attractive to both cardiologists and patients that many institutions stopped offering open heart surgery as the second procedure.

Favoring the catheter-based implantation over open-heart surgery, however, lacks data from randomized trials to prove its long-term safety and efficacy. This may be particularly relevant regarding the treatment of artificial heart valves. The REPEAT-trial is the first randomized trial to rigorously study these two interventions in 890 patients enrolled in more than 50 sites worldwide. Through the work and commitment of more than 100 doctors and scientists, it will establish evidence that will help countless individuals in the years to come.

50

/

100,000

Number of individuals that are affected per year

4/5

4 out of 5 patients receive bioprosthetic valve replacement if open heart surgery is performed

890

Target number of patients we need for the first study

>50

Centers participating in the trial

>100

Doctors and scientists working on the trial

Join the Trial

REPEAT assembles some of the world’s leading heart centers, medical professionals, and scientists from Germany, the United Kingdom, Australia, and the United States of America.

We want to expand in order to recruit participants as effectively as possible, and are looking for institutions with established Heart Teams to join the trial.

News

The University Hospital of Heidelberg is starting to enroll patients.

A funding proposal is submitted to the Australian National Health and Medical Research Council. 

Australia NHMRC
February 2026

The British Heart Foundation is granting funding to enroll patients at hospitals in the UK.

The Leipzig Heart Center is the first site to be initiated for the REPEAT Trial.

October 2025

Join The REPEAT Trial Newsletter

Be the first to receive the latest news and updates.

bottom of page