Active not recruitingNAINTERVENTIONAL

PERIGON Pivotal Trial

This study is testing a new type of artificial heart valve, called the Model 400, for people who need to replace their natural or a previously implanted aortic heart valve. The aortic valve is vital for pumping blood from your heart to your body. Researchers want to make sure this new valve is both safe to use and works well in patients over a long period. People who had this valve fitted were followed for up to 5 years, and some were followed for even longer, up to 12 years, to understand its long-term performance. This information helps doctors decide if it's a good option for future patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Cardiac Surgery

Enrolment target

1,312

Start

12 May 2014

Estimated completion

31 Dec 2035

Aortic Stenosis

What is this study about?

This study, called the PERIGON Pivotal Trial, was set up to check how well a new artificial heart valve, known as the Model 400, works for people who need a valve replacement. Your aortic valve is a crucial part of your heart, making sure blood flows out to your body properly. Sometimes these valves can become stiff or leaky, meaning they don't work as they should and need to be replaced.

The main goal of this research was to see if the Model 400 valve is both safe for patients and effective at doing its job. Researchers carefully watched people who received this valve, tracking their health and the valve's performance for several years after their operation. This kind of follow-up helps to build a clear picture of whether the new valve is a good option for people needing heart valve surgery.

The study involved many hospitals across the US, Europe, and Canada. A large number of patients took part, and their progress was monitored for up to 5 years, with some even followed for 12 years. This long-term monitoring is really important to understand how the valve holds up over time, ensuring that it provides a lasting solution for patients.

Key takeaways

The study evaluated a new artificial heart valve called the Model 400 for aortic valve problems.
It focused on both the safety and effectiveness of this new valve.
Patients were followed for a very long time, up to 12 years, to see how the valve performed.
The study helped determine if the Model 400 valve is a good treatment option for patients.
Many hospitals across different countries took part in this important research.

Who may be eligible?

To join this study, people generally needed to be adults who had significant problems with their aortic heart valve – either their natural one or one they'd had replaced before. They had to require surgery to fix or replace this valve.

It was also important that participants could attend all their follow-up appointments at the hospital where they had their surgery. They needed to understand the study and agree to take part, giving their informed consent.

However, some people couldn't join. This included those who already had another artificial valve or a ring in a different part of their heart, or who needed surgery on other heart valves at the same time. People with certain severe health problems, like active infections, or other serious heart conditions that would make surgery too risky or shorten their life expectancy to less than two years, were also not 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 an adult with an aortic valve problem that needs surgery?
Can you commit to attending all required hospital follow-up visits?
Do you understand what taking part means and agree to it?
Do you *not* have other serious heart valve issues or conditions that would make surgery very risky or limit your life expectancy?

Answer every question to see your result.

What does participation involve?

If you took part in this study, you would have received the Model 400 aortic heart valve during your surgery. After your operation, the study involved regular visits to the hospital that performed your surgery. These visits were very important for the researchers to check how you were recovering and how well your new valve was working. You would have been followed up for at least 5 years, and some patients were even followed for a total of 12 years to understand the long-term effects of the valve. These appointments would have included various health checks and tests to monitor your heart and overall well-being. There wouldn't have been any specific study medications, as the focus was on the performance of the implanted heart valve.

Potential risks and benefits

Participating in any medical study has potential benefits and risks. The potential benefit of this study for you would have been receiving the new Model 400 heart valve, which researchers hoped would improve your heart function and quality of life. However, as with any major surgery, there are risks involved, such as infection, bleeding, or complications from the anaesthesia. There were also risks associated with the study itself, like needing to attend multiple follow-up appointments. It's always important to remember that you have the right to withdraw from a study at any time, for any reason, without it affecting your medical care.

Locations (38)

University of Southern California (USC) University Hospital
Verified postcode
Los Angeles, United States
University of Colorado Hospital
Verified postcode
Aurora, United States
Hartford Hospital
Verified postcode
Hartford, United States
University of Florida Shands
Verified postcode
Gainesville, United States
Piedmont Hospital
Verified postcode
Atlanta, United States
University of Maryland Medical Center
Verified postcode
Baltimore, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
University of Michigan Cardiovascular Center
Verified postcode
Ann Arbor, United States
Minneapolis Heart Institute Foundation
Verified postcode
Minneapolis, United States
Maimonides Medical Center
Verified postcode
Brooklyn, United States
The Mount Sinai Medical Center
Verified postcode
New York, United States
New York-Presbyterian Hospital/Columbia University Medical Center
Verified postcode
New York, United States

Common questions

What is aortic stenosis?

Aortic stenosis is a condition where your aortic heart valve narrows, making it harder for blood to flow from your heart to the rest of your body.

What is the Model 400 aortic valve?

The Model 400 is an artificial heart valve that was being tested to replace a diseased or damaged aortic valve.

Why were people followed for up to 12 years?

Following people for a long time helps doctors understand how well the new valve works and lasts over many years, ensuring its long-term safety and effectiveness.

What does a 'bioprosthesis' mean?

A bioprosthesis is a type of artificial heart valve made from animal tissue, often from a pig or cow.

Why did the study reopen for a specific valve size?

The study briefly reopened to gather more information on a particular size of the valve (29mm) as required by health authorities to secure approval for its use in the US.