Active not recruitingNAINTERVENTIONAL

PARADIGM: Amplatzer Valvular Plug for PVL Closure

The PARADIGM study is looking for people who have a leaky heart valve, called a paravalvular leak (PVL), after having surgery to replace a heart valve. This leak can happen near a mechanical or biological heart valve that has been put in place in the heart's aortic or mitral position. The study wants to see if a special device, the Amplatzer Valvular Plug III (AVP III), is a safe and effective way to close these leaks. Doctors will use a thin tube (catheter) to guide and place the device without needing open-heart surgery. They will follow participants for up to a year to check how well the device works and if there are any problems.

At a glance

Status

Active not recruiting

Phase

Sponsor

Abbott Medical Devices

Enrolment target

200

Start

01 Dec 2020

Estimated completion

13 Dec 2026

Paravalvular Aortic Regurgitation

What is this study about?

When you have heart valve replacement surgery, sometimes a small gap can form next to the new valve. This gap allows blood to leak through, rather than flowing properly through the valve. This is called a paravalvular leak (PVL). These leaks can sometimes cause problems like shortness of breath or fatigue, and in some cases, they can cause a type of anaemia that requires blood transfusions.

This study, called PARADIGM, is looking at a new device designed to fix these leaks. It's called the Amplatzer Valvular Plug III (AVP III). The device is inserted using a thin tube (catheter) that goes into a blood vessel, meaning it's a less invasive procedure than open-heart surgery. The aim is for the plug to seal off the leak and help your heart work better.

The main goal of this study is to find out if the AVP III device is both safe to use and effective at closing these leaks. Researchers will be carefully monitoring people who receive the device to see how well it works, if it improves their symptoms, and if there are any side effects. This information will help doctors understand more about this treatment option for people with leaky heart valves.

Key takeaways

Tests a new device (AVP III) for leaky heart valves (PVLs).
Aims to safely close leaks after heart valve replacement surgery.
Uses a less invasive procedure with a thin tube (catheter).
Involves follow-up visits for up to one year.
Could help improve symptoms caused by PVLs.
Your participation is voluntary and you can withdraw anytime.

Who may be eligible?

You might be able to join this study if you've had a mechanical or biological heart valve fitted in your aortic or mitral position and you now have a significant leak (PVL) next to it. This leak should be causing problems like heart failure symptoms or needing regular blood transfusions because of anaemia.

Your doctor will need to check that your leak is one that can be fixed with just one AVP III device and that you are generally well enough for the procedure. You must be at least 18 years old.

However, you won't be able to join if your new heart valve is rocking significantly or if the leak is caused by a different type of valve (like one put in with a thin tube, or certain quick-fit surgical valves). You also wouldn't be suitable if you have active infections, unusual growths in your heart, or if the device couldn't be safely placed due to your heart's structure or if it would block other important areas.

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.

Have I had surgery for a mechanical or biological heart valve?
Do I have a significant leak (PVL) next to my heart valve that's causing problems or needing blood transfusions?
Am I at least 18 years old?
Do I have an active infection or other serious heart conditions that might prevent me from joining?
Am I pregnant or planning to become pregnant soon?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have the AVP III device placed to close your heart valve leak. Before the procedure, doctors will do tests like heart scans (echocardiograms), physical examinations, blood tests, and ask you to fill out questionnaires to understand your health and leak.

After the procedure, you'll have follow-up visits to check on your progress and the device. These visits will happen when you leave the hospital, and then again after about 30 days, 6 months, and 1 year. At these visits, you'll have similar tests – heart scans, physical exams, blood tests, and questionnaires – to see how well the device is working, if your symptoms have improved, and how you're feeling overall. Any health issues or side effects will be carefully recorded throughout the study.

Potential risks and benefits

Potential benefits of taking part could include having your heart valve leak successfully closed, which might improve symptoms like breathlessness or reduce the need for blood transfusions. However, as with any medical procedure, there are potential risks, including those associated with placing the device, bleeding, infection, or the device not working as expected. You will be closely monitored for any issues. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (24)

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

University Hospital - Univ. of Alabama at Birmingham (UAB)
Verified postcode
Birmingham, United States
Emory University Hospital
Verified postcode
Atlanta, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Minneapolis Heart Institute
Verified postcode
Minneapolis, United States
Saint Luke's Hospital of Kansas City
Verified postcode
Kansas City, United States
University of Nebraska Medical Center
Verified postcode
Omaha, United States
Hackensack University Medical Center
Verified postcode
Hackensack, United States
Lenox Hill Hospital
Verified postcode
New York, United States
New York Presbyterian Hospital/Cornell University
Verified postcode
New York, United States
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
Baptist Memorial Hospital
Verified postcode
Memphis, United States
Intermountain Medical Center
Verified postcode
Murray, United States

Common questions

What is a paravalvular leak (PVL)?

A PVL is a small gap that sometimes forms next to a new heart valve after surgery, allowing blood to leak through instead of flowing properly.

What is the AVP III device?

It's a special plug designed to close these leaks. It's guided into place using a thin tube, avoiding open-heart surgery.

Will I need open-heart surgery for this procedure?

No, the AVP III device is placed using a thin tube (catheter) through a blood vessel, which is a less invasive approach than open-heart surgery.

How long will the study follow me?

If you participate, you will be followed for up to one year after the procedure to check your progress and the device's effectiveness.

What happens if I decide I don't want to be in the study anymore?

You can withdraw from the study at any time, for any reason, and it will not affect the medical care you receive.