Active not recruitingNAINTERVENTIONAL

PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis

This study, called PARTNER 3, is looking at the safety and effectiveness of a new type of heart valve replacement called the SAPIEN 3 Transcatheter Heart Valve (TAVR). TAVR involves replacing the faulty valve without open-heart surgery, using a small tube inserted into a blood vessel. The study is for people with a serious heart problem called aortic stenosis, where the aortic valve doesn't open properly. This trial specifically focuses on patients who are considered low-risk for traditional open-heart surgery. It compares the new TAVR procedure with the standard open-heart surgery (SAVR) to see which is better and safer for these patients in the long run.

At a glance

Status

Active not recruiting

Phase

Sponsor

Edwards Lifesciences

Enrolment target

1,000

Start

01 Mar 2016

Estimated completion

01 Dec 2029

Aortic Stenosis

Results

Results from this study

Posted December 2021

Results have been published for this study.

Primary outcome

All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)

Number of patients that had any of these events

Full results on the registry

What is this study about?

Imagine your heart has four doors, called valves, that help blood flow in the right direction. The aortic valve is one of these important doors. In a condition called aortic stenosis, this door becomes stiff and narrow, making it hard for blood to leave your heart to go to the rest of your body. This can make you feel tired, short of breath, or have chest pain. If left untreated, it can be very serious.

Traditionally, the main way to fix this has been open-heart surgery, where doctors carefully open your chest to replace the faulty valve. However, a newer method has emerged called Transcatheter Aortic Valve Replacement (TAVR). With TAVR, doctors can replace the valve using a thin tube, usually inserted through a blood vessel in your leg, without the need for major open-heart surgery. This can often mean a quicker recovery.

This particular study, called PARTNER 3, is important because it's looking at whether TAVR is as safe and effective as traditional open-heart surgery for people who are otherwise quite healthy and would normally be good candidates for either procedure. By comparing these two methods, doctors hope to understand which option is best for different patients, especially those who are considered to have a low risk for surgery.

Key takeaways

This study compares two ways to replace a heart valve: traditional surgery (SAVR) vs. a less invasive method (TAVR).
It's for people with severe aortic stenosis who are generally healthy and considered low-risk for surgery.
Patients are randomly assigned to one of the two treatments.
You'll have regular follow-up appointments for up to 10 years to check your health.
The goal is to find out which procedure is safer and more effective for these patients long-term.

Who may be eligible?

To be considered for this study, you would typically have severe aortic stenosis, meaning your aortic valve is very narrowed. You might be feeling symptoms like shortness of breath during activity, or your heart might show signs of strain. Importantly, a team of heart doctors would need to agree that your overall health means you're considered to have a low risk for standard open-heart surgery.

There are also some reasons why you might not be able to join. For example, if your aortic valve is an unusual shape, or if the blood vessels doctors would use for the TAVR procedure aren't suitable. Also, if you’ve recently had a heart attack or stroke, or have other serious heart or blood conditions, you might not be able to take part. Your specialist team will carefully check all these details to see if this study is right for 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.

Do I have severe narrowing of my aortic heart valve (aortic stenosis)?
Do I experience symptoms like shortness of breath or fatigue, or has my heart shown signs of strain?
Has my heart team told me I am generally healthy and low-risk for major heart surgery?
Am I open to having either traditional surgery or the newer TAVR procedure, depending on what the study assigns me?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have a detailed discussion about the study and provide your written agreement. You would then be randomly assigned, like flipping a coin, to either have the standard open-heart surgery to replace your aortic valve, or to have the newer TAVR procedure with the SAPIEN 3 valve. Neither you nor your doctor would choose which treatment you receive.

After your procedure, you would have follow-up visits with the study team at specific times: when you leave the hospital, then at 30 days, 6 months, and once a year for up to 10 years. These visits will involve checks to see how you're recovering and how well your new valve is working. Some patients might also be asked to take part in additional checks like wearing a special activity monitor or filling out questionnaires about their quality of life.

Potential risks and benefits

Taking part in this study could offer you access to a new valve replacement procedure. For some patients, TAVR might lead to a faster recovery compared to traditional surgery, and you would receive very close monitoring of your health over many years. However, like any medical procedure, both TAVR and open-heart surgery carry risks, such as bleeding, infection, or complications related to the heart. Your dedicated care team will explain all the potential risks and benefits in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (77)

University of Alabama
Verified postcode
Birmingham, United States
Banner University Medical Center
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Phoenix, United States
Mills/Peninsula Health Services
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Burlingame, United States
Cedars-Sinai Medical Center
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Los Angeles, United States
University of California, Los Angeles/Ronald Reagan Medical Center
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Los Angeles, United States
Hoag Hospital
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Newport Beach, United States
Stanford Hospital and Clinics
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Palo Alto, United States
Sutter Health Sacramento
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Sacramento, United States
Kaiser Permanente San Francisco
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San Francisco, United States
UC Health Northern Colorado/Medical Center of the Rockies
Verified postcode
Loveland, United States
Hartford
Verified postcode
Hartford, United States
JFK Medical Center / Atlantic Clinical Research Collaborative
Verified postcode
Atlantis, United States

Common questions

What is Aortic Stenosis?

Aortic stenosis is when your heart's aortic valve becomes narrow and stiff, making it harder for blood to flow out of your heart to your body.

What is TAVR?

TAVR (Transcatheter Aortic Valve Replacement) is a way to replace a faulty heart valve using a thin tube inserted through a blood vessel, usually in the leg, without major open-heart surgery.

What is SAVR?

SAVR (Surgical Aortic Valve Replacement) is the traditional open-heart surgery where your chest is opened to replace your aortic valve.

Who is considered 'low risk'?

In this study, 'low risk' means a team of heart doctors believes you are generally healthy enough that open-heart surgery would likely be safe for you, with a very low chance of serious complications.

How long will I be followed up in the study?

If you join the study, you will have regular check-ups for up to 10 years to monitor your health and the new valve.