The REPEAT Trial

​​REpeat Intervention for Deteriorated Surgical BioProsthEtic AorTic Valves (REPEAT)

• IRAS ID: 359609
• Clinicaltrials.gov: NCT07462624

Why is this research being done?

Surgical Aortic Valve Replacement (SAVR) is an operation to replace one of the valves in the heart.

It is the best way to treat patients whose valve has become narrow or leaky.

The replacement valve can either be mechanical (made from metal) or biological (made from animal tissue). 

Biological valves can fail over time and when this happens, the valve needs replacing again. There are two options for this second valve procedure; 

1. Repeat Surgical Aortic Valve Replacement (rSAVR) 

This surgery opens the chest up to access the heart (open heart surgery) and replaces the valve again, like the first surgery. 

2. Valve-in-Valve Transcatheter Aortic Valve Replacement (ViV-TAVR) 

The ViV-TAVR procedure involves inserting a new valve into the current valve using a narrow flexible tube (called a catheter).

It is called a keyhole approach because it doesn’t involve opening your chest up to access the heart.  

The aim of the REPEAT trial is to compare rSAVR and ViV-TAVR to decide which is better in the long term so we can make sure patients are getting the best treatment going forward. 

What happens to me if I agree to take part in this research?

If you decide to take part in this research study, the treatment you receive will be decided using a randomisation process.

This means that your doctors have decided that both procedures are safe for you, but the decision about which procedure you receive will be made using a computer.

There is equal chance of being allocated to each group (like tossing a coin). 

Your journey through the study

Before your procedure, you’ll have had all your routine tests, including an echocardiogram (which is a test that uses ultrasound waves to take pictures of your heart) and we’ll ask you some questions about your health.

We will ask you to complete some questionnaires, have a physical examination and complete a six-minute walking test.

The procedure and your hospital stay will then take place as per routine hospital care.   

For the next 5 years following your procedure you will be asked to come back to the hospital to undergo some tests:  

1 year after your procedure:

• Questionnaires about your health and quality of life
• Echocardiogram

2 years after your procedure

• Telephone call (questions about your health)

3 years after your procedure

• Questionnaires about your health and quality of life
• Echocardiogram

4 years after your procedure

• Telephone call (questions about your health)

5 years after your procedure

• Questionnaires about your health and quality of life
• Echocardiogram
• Walking tests

How many people will take part in this research? 

REPEAT aims to recruit 890 patients internationally, with 178 in the UK.  

Where is this research taking place?

The trial will be carried out in more than 50 experienced clinical centres in the USA, Canada, Germany, Australia and the UK.  

We aim to deliver this trial across 12 locations in the UK (see table below for details).

How do I take part in this study?

In the first instance, speak to your usual heart care team. They will be able to provide further information about taking part in REPEAT, or signpost you to a recruiting hospital (if the hospital where you normally receive your care is not a recruiting hospital).  

You can also contact the central study team via email [email protected]  

Who is organising and funding the study?

The study was founded and is being led by teams at the University of Leipzig and Helios Health Institute in Germany.

 In the UK, South Tees Hospitals NHS Foundation Trust is organising this study and is known as the ‘Sponsor’. 

The Academic Cardiovascular Unit is the UK Coordinating centre, and funding has been provided by the British Heart Foundation.