The TRISCEND II logo

Learn more about this clinical trial

The TRISCEND II clinical trial is to determine the safety and effectiveness of the EVOQUE valve, a device designed to replace the tricuspid valve with no open heart surgery.

This trial is for patients with severe or greater tricuspid regurgitation.

Talk to your doctor to determine if this trial is right for you.

Heart Icon

What is Tricuspid Valve Regurgitation?1

Tricsupid regurgitation (TR) occurs when the tricuspid valve in your heart does not close all the way, usually because the valve has dilated, or stretched, and its leaflets don't close tightly. This allows blood to flow backwards within the heart, and if severe may cause symptoms such as shortness of breath with activity and swelling in your abdomen, legs, or veins in your neck.

See comparison between healthy heart and one with tricsupid regurgitation

Move the arrow left or right to see comparison

Tricuspid Regurgitation vs healthy heart

Degenerative mitral regurgitation slider (1/2) Healthy heart slider (2/2)

EVOQUE System vs healthy heart

Functional mitral regurgitation slider (1/2) Healthy heart slider (2/2)

TR may be treated by repairing or replacing the tricuspid valve. Learn more about the TRISCEND II trial for tricuspid regurgitation treatment below.1,3

Edwards EVOQUE Tricuspid Valve Replacement System

Edwards EVOQUE Tricuspid Valve Replacement System

What is the EVOQUE tricuspid valve replacement system?

The Edwards EVOQUE tricuspid valve replacement system is an investigational device designed to replace your native tricuspid valve without open-heart surgery. The valve is implanted using a minimally invasive delivery system where your doctor places a thin tube through a vein in your leg to reach your heart and perform the valve replacement procedure.

EVOQUE Implant

EVOQUE Implant

See how it works

Watch the EVOQUE valve procedural animation

What you should know about the TRISCEND II clinical trial

This trial is intended to evaluate the safety and effectiveness of the EVOQUE valve with Optimal Medical Therapy (OMT) compared to OMT alone in patients with severe or greater TR.2

New medical devices are made available to people on a regular basis. However, before they can be offered to the public, they need to be studied for how safe they are and how well they work.

A clinical trial is a type of research conducted with volunteers that studies recently developed medications or treatments.3,4

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The TRISCEND II clinical trial will evaluate the safety and effectiveness of an investigational device designed to treat severe and greater TR by replacing the tricuspid valve using a transcatheter procedure (without open heart surgery).2

  • A transcatheter procedure will be used to replace your tricuspid valve in this clinical trial
  • You may receive the EVOQUE replacement valve while remaining on optimal medical therapy (OMT), or optimal medical therapy alone5
  • This clinical study will allow doctors to understand how the EVOQUE valve works in patients like you
The EVOQUE valve

The EVOQUE
valve

Medication

Medication

  • You will be informed of the potential risks and benefits of participating in the TRISCEND II clinical trial and given ample time to ask questions about the research. Your participation is completely voluntary.
  • You will be enrolled randomly in either the Test Group (receiving the EVOQUE valve and Optimal Medical Therapy) or the Control group (receiving only Optimal Medical Therapy).
  • You will be monitored throughout the procedure and after implantation of the device. This will require you to come in for several follow-up visits over a 5-year period5
  • During the trial, you will have a team of experts—your Heart Team—to guide and support you from beginning to end.5

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  • The tests or procedures required by the research trial that would not otherwise be part of your standard care will be covered by Edwards Lifesciences, the Sponsor of this trial.
  • You will still be responsible for the cost of your usual ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider.

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Are You a Candidate?

You may be eligible for this trial if you’re an adult and you have severe or greater, and symptomatic tricuspid regurgitation, as determined by your heart team.

Ask your doctor or research coordinator for the full list of criteria. If you choose to participate, you will be asked to complete health and imaging assessments to ensure you meet the criteria to continue in the clinical trial.

For more information

For more information

We're here for you. If you have questions about the trial, please call the Edwards Patient Support Center at 888-713-1564 or email us at patient_support@edwards.com. For details about the trial, visit www.clinicaltrials.gov and search "NCT04482062."

References:

  1. Tricuspid valve regurgitation. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/symptoms-causes/syc-20350168.
  2. Edwards TRISCEND II pivotal clinical trial protocol (TRISCEND II). ClinicalTrials.gov identifier: NCT04482062. Updated January 13, 2021. Accessed January 1, 2021. https://clinicaltrials.gov/ct2/show/NCT04482062.
  3. Clinical trials: what patients need to know. US Food and Drug Administration. Updated January 4, 2018. Accessed August 24, 2020. https://www.fda.gov/patients/ clinical-trials-what-patients-need-know.
  4. Inside Clinical Trials: Testing Medical Products in People. US Food and Drug Administration. Updated November 6, 2014. Accessed August 25, 2020. https://www.fda.gov/drugs/drug- information-consumers/inside-clinical-trials-testing-medical-products-people.
  5. Edwards EVOQUE Tricuspid Valve Replacement System: Instructions for Use. Edwards Lifesciences.

Important safety information

Important safety information

CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use. This device is not available for marketing or commercial sale in the United States.

Edwards Lifesciences is the sponsor of the TRISCEND II trial.

Edwards, Edwards Lifesciences, the stylized E logo, EVOQUE, and TRISCEND are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners

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