The JOURNEY trial

Now enrolling

About the JOURNEY trial

The JOURNEY trial will evaluate the safety and effectiveness of the investigational  J‑Valve transfemoral (TF) transcatheter aortic valve implantation aortic regurgitation (TAVI-AR) system for the treatment of symptomatic, severe aortic regurgitation in patients who are at high surgical risk for valve implantation by open heart surgery.

What is aortic regurgitation

Aortic Regurgitation (AR) is also known as aortic insufficiency, and is diagnosed when your aortic valve allows blood to leak back into your heart instead of moving forward into your aorta.

Normally, your aortic heart valve opens and closes to let blood flow from your heart's left ventricle, into your aorta, and out through your body. A leaking (or regurgitant) valve means your valve doesn't close all the way and allows the blood to flow backwards into your ventricle.

When your blood moves backwards, it forces your heart to work harder to push blood out to your body. This extra work causes your heart to grow in size (enlarge). Over time as your heart enlarges, the extra work can create symptoms and even lead to heart failure.

Symptoms can include:

Chest pain

Lightheadedness or fainting

Fatigue and weakness

Irregular heartbeat

Shortness of breath

Swelling of the feet

What is TAVI-AR

Transcatheter Aortic Valve Implantation for Aortic Regurgitation (TAVI-AR) may be a minimally invasive treatment for patients who are at high risk for open heart surgery. The purpose of the TAVI-AR procedure is to replace your leaking aortic valve with a bioprosthetic valve (a man-made valve containing animal tissue). We are studying the safety and performance of the investigational J-Valve device for patients with aortic valve regurgitation. This implantation is one way to treat aortic regurgitation or aortic valve insufficiency.

The Edwards J-Valve transcatheter heart valve

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Step 1

For the TAVI procedure, a small incision will be made in your leg. Through here, your doctor will insert a thin tube, called a catheter, into your artery.

Step 2

The study valve is compressed and attached to the end of the catheter. The catheter will be pushed through your blood vessels up to your heart using x-ray guidance.

Step 3

Special anchor rings are placed around your valve leaflets. These will help the study valve stay in place inside your heart.

Step 4

The study valve is then placed within the anchor rings that help it stay secure inside the heart. It expands into place inside your diseased aortic valve.

Step 5

The study valve holds your diseased valve open and takes over its function. After the study valve is implanted, your doctor will remove the catheter and delivery device, and close the incision in your leg.

Step 1

Step 2

Step 3

Step 4

Step 5

Step 1

For the TAVI procedure, a small incision will be made in your leg. Through here, your doctor will insert a thin tube, called a catheter, into your artery.

Step 2

The study valve is compressed and attached to the end of the catheter. The catheter will be pushed through your blood vessels up to your heart using x-ray guidance.

Step 3

Special anchor rings are placed around your valve leaflets. These will help the study valve stay in place inside your heart.

Step 4

The study valve is then placed within the anchor rings that help it stay secure inside the heart. It expands into place inside your diseased aortic valve.

Step 5

Are You a Candidate?

You may be eligible for this trial if you:

have severe, symptomatic, aortic regurgitation
are at high risk for open surgical aortic valve replacement

Your doctor and/or research team will discuss with you the full list of criteria for participating in this trial.

Frequently asked questions

We're here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center.

For details about the trial, visit NCT06455787 at Clinical Trials.gov.

Give us a call

0870.606.2040

Send us an email

patient_support@edwards.com

CAUTION: Investigational device.

CAUTION: Exclusively for clinical investigations. To be used by qualified investigators only. Not available for commercial use until validly CE marked.
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