RecruitingNAINTERVENTIONAL

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

This important study looks at two different approaches to fix a leaky heart valve, called mitral regurgitation, in adults aged 60 and older. The two treatments being compared are a keyhole procedure, known as transcatheter edge-to-edge repair (TEER), and traditional open-heart surgery. Doctors want to understand which method is better in the long run for improving a person's health, preventing hospital stays for heart problems, and boosting their overall quality of life. Participants will be randomly assigned to receive one of these treatments, and their health will be followed for up to 10 years to gather detailed information. This trial is happening in several countries, including the UK, and uses commonly available versions of the keyhole repair technique.

At a glance

Status

Recruiting

Phase

Sponsor

Annetine Gelijns

Enrolment target

450

Start

21 Feb 2022

Estimated completion

15 Nov 2030

Mitral Valve Regurgitation

What is this study about?

When your heart beats, it pumps blood around your body. Inside your heart, there are valves that act like one-way doors to make sure blood flows in the right direction. If one of these valves, called the mitral valve, becomes leaky, it means some blood flows backward. This condition is called mitral regurgitation, and it can make your heart work harder and cause symptoms like breathlessness or tiredness. If this leak is severe and caused by wear and tear (degenerative), doctors might suggest fixing it.

There are generally two main ways to fix a leaky mitral valve: open-heart surgery or a less invasive keyhole procedure called transcatheter edge-to-edge repair (TEER). In open-heart surgery, doctors make an incision to reach the heart and repair the valve. TEER uses thin tubes (catheters) to reach the heart through a blood vessel, usually in the leg, to clip the valve leaflets together, reducing the leak. This study wants to compare these two options in people aged 60 and over who have a severe leaky mitral valve.

The main goal is to find out which treatment is better for people's health in the long run, comparing how safe they are and how well they reduce the leak. Researchers will also look at how these treatments affect quality of life, how well people can do daily activities, and if they need to go into hospital for heart problems. This information will help doctors decide the best way to treat patients with this condition in the future.

Key takeaways

Compares two ways to fix a leaky heart valve: keyhole surgery (TEER) vs. open-heart surgery.
Aimed at people aged 60 and over with a severe leaky mitral valve.
Will track health outcomes for up to 10 years to see which works best long-term.
Helps doctors understand the best treatment choice for future patients.
Participation involves routine follow-up tests and health checks after the procedure.

Who may be eligible?

This study is looking for adults who are 60 years old or older and have a severe leaky mitral valve that needs fixing. Importantly, your heart specialist team must agree that both the keyhole procedure (TEER) and traditional surgery are suitable options for you based on your specific heart condition and anatomy. This means your valve must be repairable by both methods.

Doctors will carefully check various aspects of your health to make sure you are a good fit for the study. For instance, you should be able to do a short walking test and complete a questionnaire about your health. The study welcomes participants regardless of their gender, background, or ethnicity.

However, there are also reasons why someone might not be able to join. For example, if your leaky valve is caused by something other than general wear and tear, or if you have certain other heart conditions. You also can't participate if you have allergies to certain dyes used in medical tests or have had a recent fever. Your medical team will go through all these details with 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.

Are you 60 years or older?
Do you have a severe leaky mitral valve that needs treatment?
Have your heart doctors confirmed that both keyhole repair and open-heart surgery are suitable for you?
Can you do a short walking test and answer health questionnaires?
Do you have any other serious heart conditions that might prevent you from joining?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be randomly assigned to receive either the keyhole repair (TEER) or traditional surgery. This is like flipping a coin, so neither you nor your doctor can choose which treatment you get. Both treatments are aimed at fixing your leaky heart valve.

After your procedure, you'll have regular follow-up appointments and tests over a period of 5 years to check how well your valve is working and how you are feeling generally. Some participants may even be followed for up to 10 years for specific health outcomes. These follow-up visits will involve checking your heart, perhaps through scans like echocardiograms, and answering questions about your health and quality of life. The study aims to recruit volunteers over about three years.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you would receive one of two established treatments for your heart condition, and the close monitoring might help catch any issues early. You would also be contributing valuable information that could help improve care for future patients. However, both keyhole procedures and open-heart surgery carry risks, such as bleeding, infection, or problems with the heart. Your doctors will discuss these risks specific to your health condition and the chosen treatment in detail. You have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (61)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Keck Hospital of the University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Recruiting
University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Recruiting
Piedmont Heart Institute
Verified postcode
Atlanta, United States· Recruiting
Emory University
Verified postcode
Atlanta, United States· Recruiting
Ochsner Clinic
Verified postcode
New Orleans, United States· Recruiting
Maine Medical Center
Verified postcode
Portland, United States· Recruiting
The Johns Hopkins Hospital
Verified postcode
Baltimore, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Brigham and Women's
Verified postcode
Boston, United States· Recruiting
University of Michigan Hospital
Verified postcode
Ann Arbor, United States· Recruiting

Common questions

What is 'mitral regurgitation'?

It means your heart's mitral valve is leaky, causing some blood to flow backward instead of forward. This can make your heart work harder.

What are the two treatments being compared?

Doctors are comparing a keyhole procedure called TEER (Transcatheter Edge-to-Edge Repair) with traditional open-heart surgery to fix the valve.

How will I know which treatment I'll get?

You'll be randomly assigned to one of the two treatments, like drawing lots. You and your doctor won't choose.

How long will I be followed in the study?

Your health will be monitored for at least 5 years after your procedure, and for some, up to 10 years.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, and it won't affect the care you receive from your doctors.

How to find out more

Chari Ponder, RN, BSN

chari.ponder@mountsinai.org (646) 899-8106 Official trial record

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