RecruitingNAINTERVENTIONAL

PRIMARY Ancillary Substudy

This study, called PRIMARY Ancillary Substudy, is part of a larger trial comparing two ways to fix a leaky heart valve (mitral valve prolapse): heart surgery (mitral valve repair) or a less invasive procedure using a special clip (transcatheter edge-to-edge repair, or TEER). Researchers want to understand how these treatments affect your heart's structure and function. They're particularly interested in why some people with leaky valves develop abnormal heart rhythms. By using tests like heart scans (MRI) and rhythm monitors, and sometimes small tissue samples from surgery, they hope to learn more. This knowledge could help doctors figure out which treatment is best for you, reduce the chances of serious heart problems, and improve long-term health for people with this condition. The study involves looking at information from about 250 patients over about a year.

At a glance

Status

Recruiting

Phase

Sponsor

Annetine Gelijns

Enrolment target

250

Start

16 Oct 2023

Estimated completion

30 Jun 2027

Mitral Valve Prolapse Left Ventricular Fibrosis Ventricular Arrhythmias

What is this study about?

You might have heard of a condition called mitral valve prolapse (MVP), which means one of the valves in your heart doesn't close properly, causing a leak. This study, called PRIMARY Ancillary Substudy, is designed to help us understand why some people with MVP can develop problems with their heart's rhythm or how well their heart pumps blood. Think of it like trying to figure out why a car engine might start sputtering – sometimes it's a small issue, and sometimes it's more serious. In this study, we're looking at the heart muscle itself to see how it changes over time with MVP and different treatments.

The main goal of this study is to compare two common ways doctors can fix a leaky mitral valve: a surgical repair (where a surgeon fixes the valve) or a procedure using a special clip threaded through a blood vessel (called TEER). We want to see how each of these treatments affects your heart, especially how it might stop or reduce changes in the heart's structure and function that could lead to rhythm problems or heart failure. By carefully checking your heart with scans and monitors before and after treatment, we hope to find out which method is better at preventing these issues and improving your overall heart health. The study involves looking at information from about 250 patients in highly experienced heart centers across several countries, including the UK.

Ultimately, the knowledge gained from this study is really important. It could help doctors make more informed decisions about which treatment option is best for different individuals with mitral valve prolapse. This could lead to better long-term outcomes for patients, by reducing the chances of developing serious heart problems like heart rhythm disturbances or heart failure. We're also trying to find ways to predict how well a treatment might work for you based on specific markers in your heart, almost like creating a personalised heart health forecast.

Key takeaways

This study compares two treatments for leaky heart valves (mitral valve prolapse).
It aims to understand why some people get heart rhythm problems and how treatments affect this.
Tests include heart scans (MRI) and wearing a heart rhythm monitor.
It could help doctors choose the best treatment for you in the future.
You must already be in the main PRIMARY study to join this part.
Participation lasts about 12 months after your heart procedure.

Who may be eligible?

To be part of this special study, you must first be eligible for and already taking part in the main PRIMARY study. This means you would have already been randomly chosen to receive either the surgical heart valve repair or the clip procedure (TEER).

If you are one of the patients in the main trial chosen to have the surgical repair, you might also be asked if doctors can take a very small sample of heart tissue during your operation. This extra step helps us understand more about the heart muscle itself. The study is open to both men and women, generally aged 60 and above, with no upper age limit.

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 already taking part in the main PRIMARY heart valve study?
Are you 60 years old or older?
Do you feel comfortable with medical scans like an MRI?
Do you have any known allergies to the dye used in MRIs?
Are you comfortable wearing a heart rhythm patch on your skin?
If having surgery, are you okay with a tiny tissue sample being taken?

Answer every question to see your result.

What does participation involve?

If you join this study, you will already be part of the main PRIMARY trial. This means you'll have regular checks, including a specific type of ultrasound of your heart called an echocardiogram. For this additional study, you might also have one or more heart MRI scans, which are detailed pictures of your heart. You would also wear a special monitor called a ZioPatch, which sticks to your skin and records your heart's rhythm over several days. If you are having surgical repair, you might have a very small piece of heart tissue taken during the operation.

All these tests will happen before your heart valve procedure and again about a year afterwards. The study is designed to follow your progress for up to 12 months after your treatment. You won't be given any new medications specifically for this study. The total duration of your active participation, beyond the main trial's usual follow-up, will be around 12-18 months from when you start.

Potential risks and benefits

Taking part in this study could help us learn more about how to best treat leaky heart valves, potentially leading to better care for people like you in the future. There are some small risks involved, such as potential discomfort from MRI scans (especially if you don't like small spaces) or very rare reactions to the special dye sometimes used in MRI. There's also a tiny chance of skin irritation from the heart rhythm monitor. If you have the tissue biopsy, this is done during surgery and adds no extra surgical risk. You have the right to withdraw from this additional study at any time without affecting your medical care in the main PRIMARY trial.

Locations (25)

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
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
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
University of Michigan Hospital
Verified postcode
Ann Arbor, United States· Recruiting
Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
Verified postcode
Kansas City, United States· Recruiting
Weill Cornell Medicine/ New York-Presbyterian Hospital
Verified postcode
New York, United States· Recruiting
Northwell--Lenox Hill, North Shore, South Shore, Staten Island University Hospital
Verified postcode
New York, United States· Recruiting

Common questions

What is the main purpose of this study?

To understand how different ways of fixing a leaky heart valve affect your heart and prevent rhythm problems or heart failure.

Who can join this study?

You must already be participating in the main PRIMARY trial comparing heart valve treatments, and mostly aged 60 or over.

What additional tests will I have?

You might have extra heart MRI scans and wear a heart rhythm monitor. If you have surgery, a small tissue sample might be taken.

Are there any risks to taking part?

Small risks include discomfort from MRI or skin irritation from the monitor. All efforts are made to ensure your safety.

Can I stop participating in the study?

Yes, you can withdraw from this study at any time without it affecting your medical care for your heart condition.

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.