RecruitingNAINTERVENTIONAL

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

This important study is looking into a new treatment called the Edwards PASCAL Transcatheter Valve Repair System. It's designed for people with severe tricuspid regurgitation, a condition where one of the heart's valves doesn't close properly, causing blood to leak backward. This can lead to symptoms like tiredness, breathlessness, and swelling. The study wants to find out if this new device, when used alongside the best available medical treatments, is safe and more effective than just having medical treatment on its own. The goal is to help patients feel better and improve their quality of life. Doctors will carefully check if you might benefit from this study and if it's right for you.

At a glance

Status

Recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

1,270

Start

11 Dec 2019

Estimated completion

31 Dec 2031

Tricuspid Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease

What is this study about?

This study is investigating a new procedure and device called the Edwards PASCAL Transcatheter Valve Repair System. It's designed for people who have a heart condition called tricuspid regurgitation, sometimes shortened to TR. TR means that the tricuspid valve, one of the four valves in your heart, isn't closing tightly enough. When this happens, some blood leaks backward through the valve each time your heart beats, making your heart work harder. This can lead to symptoms like feeling very tired, short of breath, or having swelling, especially in your legs.

Currently, doctors treat severe TR with medications to help manage symptoms, and sometimes surgery is an option for certain patients. However, surgery can be a big operation with risks, and not everyone is suitable for it. This new PASCAL device aims to fix the leaky valve using a less invasive procedure, meaning it doesn't involve open-heart surgery. The device is delivered through a small tube that goes into a blood vessel.

The main goal of this particular study is to see how safe and effective the Edwards PASCAL System is for people with severe TR. Doctors want to know if it can help reduce the leak in the valve, improve symptoms, and make patients feel better compared to just using standard medical treatments. Your local heart team, which includes different heart specialists, will carefully consider if you might benefit from participating in this study.

Key takeaways

The study tests a new device (Edwards PASCAL) for leaky heart valves.
It aims to improve symptoms and safety for severe tricuspid regurgitation.
Participants will either get the device or standard medical care, chosen randomly.
Regular follow-up appointments are needed for up to 5 years.
It's for people whose heart surgeon feels open-heart surgery is too risky.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have severe tricuspid regurgitation (a very leaky heart valve) that is causing you symptoms, even though you are already receiving medical treatment. These symptoms might include feeling breathless, tired, or having swelling, or you may have been hospitalised for heart failure in the last year.

Your heart surgeon and the local heart team must agree that surgery to fix your tricuspid valve carries an intermediate or higher risk for you. This means they think surgery might be too risky or not the best option. You also need to be willing and able to understand what the study involves, give your consent to take part, and be able to come for all the necessary follow-up appointments.

There are also some reasons why you might not be able to join. For example, if the doctors can't get a good look at your tricuspid valve using scans, or if your valve's shape would prevent the device from working properly. Also, if you have other serious heart problems like advanced heart failure requiring special devices, or certain recent health issues like a stroke or blood clots, you might not be eligible.

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 18 years old or older?
Do you have severe tricuspid regurgitation (leaky heart valve)?
Are your symptoms (breathlessness, tiredness, swelling) still bothering you despite medication?
Has your heart team said that open-heart surgery might be too risky for you?
Are you willing to attend regular follow-up visits for up to 5 years?

Answer every question to see your result.

What does participation involve?

If you join this study, you will either receive the Edwards PASCAL System plus your usual medical care, or you will continue with your usual medical care alone. The study is "randomized," meaning a computer will decide which group you are in, like flipping a coin.

If you receive the Edwards PASCAL System, it's a procedure where a small device is put into your heart to help repair the leaky valve. Throughout the study, all participants will have regular medical appointments and check-ups. You'll need to attend follow-up visits at discharge from the hospital, then again after 30 days, 3 months, and 6 months. After that, you'll have yearly checks for up to 5 years. These visits will involve various tests to monitor your heart health and symptoms. The total duration of your participation, including follow-up, could be up to 5 years.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new treatment (the Edwards PASCAL System) that could improve your heart valve function and reduce your symptoms like breathlessness and tiredness. However, like any medical procedure or trial, there are potential risks, including those associated with the device placement or any medical tests. You will be told about all known risks specific to your situation. Remember, you can choose to withdraw from the study at any time without affecting your usual medical care.

Locations (79)

Banner University Medical Center Phoenix
Verified postcode
Phoenix, United States· Active not recruiting
Tucson Medical Center Healthcare
Verified postcode
Tucson, United States· Active not recruiting
University of California, Irvine
Verified postcode
Irvine, United States· Recruiting
SCPMG - Kaiser San Diego
Verified postcode
La Jolla, United States· Active not recruiting
Cedars Sinai Medical Center
Verified postcode
Los Angeles, United States· Active not recruiting
UCLA Medical Center
Verified postcode
Los Angeles, United States· Active not recruiting
Kaiser Permanente San Francisco
Verified postcode
San Francisco, United States· Active not recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Stanford University
Verified postcode
Stanford, United States· Active not recruiting
St. Joseph Hospital
Verified postcode
Denver, United States· Recruiting
Medical Center of the Rockies
Verified postcode
Loveland, United States· Active not recruiting
The Cardiac and Vascular Institute Research Foundation
Verified postcode
Gainesville, United States· Recruiting

Common questions

What is tricuspid regurgitation?

It's when one of your heart's valves (the tricuspid valve) doesn't close properly, causing blood to leak backward in your heart.

What is the Edwards PASCAL System?

It's a special device designed to fix a leaky tricuspid valve without needing open-heart surgery, aiming to reduce the backward blood flow.

Will I definitely receive the new device?

Not necessarily. The study involves two groups: one receives the device plus standard care, and the other receives standard care alone. Which group you're in is decided randomly.

How long will I be in the study?

Your involvement in the study, including follow-up appointments, could last for up to 5 years.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any point, and this will not affect the medical care you receive.

How to find out more

Edwards TMTT Clinical Affairs

tmtt_clinical@edwards.com (949) 250-2500 Official trial record

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