Active not recruitingNAINTERVENTIONAL

Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI).

This study, called SURTAVI, is designed to find out how safe and effective a new keyhole procedure, called Transcatheter Aortic Valve Implantation (TAVI), is compared to traditional open-heart surgery (Surgical Aortic Valve Replacement or SAVR). Both procedures aim to replace a faulty heart valve in people with a serious condition called severe aortic stenosis. Researchers are particularly interested in patients who have a moderate level of risk for surgery. Doctors will decide which treatment is best for each patient based on their health. Another part of the study looks only at the keyhole TAVI procedure for these patients, without directly comparing it to surgery, to understand its safety and how well it works.

At a glance

Status

Active not recruiting

Phase

Sponsor

Medtronic Cardiovascular

Enrolment target

1,746

Start

01 Apr 2012

Estimated completion

01 Nov 2026

Severe Aortic Stenosis

What is this study about?

This study, called SURTAVI, is looking into the best ways to treat a serious heart condition called severe aortic stenosis. This happens when the main valve that lets blood leave your heart (the aortic valve) becomes stiff and narrow. This makes your heart work much harder to pump blood around your body, and can lead to symptoms like breathlessness, chest pain, or feeling faint.

Traditionally, a faulty aortic valve has been replaced with open-heart surgery, known as Surgical Aortic Valve Replacement (SAVR). However, a newer, less invasive procedure, called Transcatheter Aortic Valve Implantation (TAVI), has been developed. With TAVI, a new valve is put in place using a thin tube (catheter) inserted through a blood vessel, often in the leg, avoiding the need to open up the chest.

This study aims to compare these two methods – TAVI and SAVR – in people who need a new aortic valve and are considered to have an 'intermediate' risk for surgery. This means their health makes surgery a bit more risky than for very fit people, but not as risky as for very frail people. By comparing the two, doctors hope to understand which method is safer and works better for this group of patients.

Key takeaways

Compares two ways to replace a heart valve: keyhole (TAVI) vs. open surgery (SAVR).
Focuses on people with severe aortic stenosis and a moderate surgical risk.
Aims to find out which treatment is safer and works better.
Requires regular follow-up appointments after the procedure.
Participation involves either TAVI or SAVR, decided by chance for most.

Who may be eligible?

To join this study, a team of heart specialists must agree that you have severe aortic stenosis and that replacing your aortic valve is the right step for you. They should also agree that you have what's called an 'intermediate' risk for traditional open-heart surgery. This isn't a firm category, but generally means your risk of complications from surgery is somewhere between 3% and 15%.

You must have clear symptoms from your narrow aortic valve, such as feeling breathless or tired, and tests like an ultrasound of your heart (echocardiogram) must show that your valve is very narrow. You also need to be willing to attend all follow-up appointments after the procedure. Your doctors will explain all the details and make sure you understand what's involved.

There are also reasons you might not be able to join. For example, if you absolutely refuse to consider open-heart surgery as an option, or if you have certain allergies to materials used in the new valve or medicines like blood thinners. Also, if you have certain blood disorders, you might not be suitable.

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 experts agree you need your aortic valve replaced?
Do you have moderate risk for traditional open-heart surgery?
Are you experiencing symptoms from your narrow heart valve?
Can you commit to all follow-up appointments?
Are you able to take necessary medications like blood thinners?

Answer every question to see your result.

What does participation involve?

The study involves either having the keyhole TAVI procedure or open-heart surgery (SAVR) to replace your faulty aortic valve. Which treatment you receive will be decided by chance, like flipping a coin, so it's fair for everyone. You will then have follow-up appointments after your procedure to check how you are doing, how well the new valve is working, and to monitor your overall health over time. The study team will explain exactly what these visits involve and how long they will last. It's important that you are able to commit to all these scheduled appointments.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving one of the most advanced treatments for severe aortic stenosis, with careful monitoring from medical experts. However, like all medical procedures, TAVI and SAVR both carry potential risks such as bleeding, infection, or problems with the new valve, which your doctors will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (86)

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

Banner Good Samaritan Medical Center
Verified postcode
Phoenix, United States
Cedars-Sinai Medical Center
Verified postcode
Hollywood, United States
Scripps Green Hospital
Verified postcode
La Jolla, United States
Keck Medical Center of USC
Verified postcode
Los Angeles, United States
El Camino Hospital
Verified postcode
Mountain View, United States
VA Palo Alto Health Care System
Verified postcode
Palo Alto, United States
Southern California Permenente Medical Group
Verified postcode
Pasadena, United States
Stanford University Medical Center
Verified postcode
Stanford, United States
Hartford Hospital
Verified postcode
Hartford, United States
Yale New Haven Hospital
Verified postcode
New Haven, United States
Washington Hospital Center
Verified postcode
Washington D.C., United States
Morton Plant Hospital
Verified postcode
Clearwater, United States

Common questions

What is severe aortic stenosis?

It's a serious heart condition where the main valve letting blood out of your heart becomes stiff and narrow, making your heart work too hard.

What's the difference between TAVI and SAVR?

TAVI is a keyhole procedure using a thin tube, while SAVR is traditional open-heart surgery. Both replace the faulty valve.

What does 'intermediate risk' mean?

It means your risk for complications from open-heart surgery is not very low but also not very high. Your doctor will assess this carefully.

Will I get to choose which procedure I have?

For the main part of the study, the procedure you receive (TAVI or SAVR) will be decided by chance, like a lottery.

Can I stop being part of the study if I change my mind?

Yes, you are free to leave the study at any time without it affecting your medical care.