The TRISCEND II trial for tricuspid regurgitation
Patient information
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.
What is tricuspid valve regurgitation?1
Tricuspid 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 tricuspid regurgitation
Move the arrow left or right to see comparison
EVOQUE system vs healthy heart
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
What is the EVOQUE tricuspid valve replacement system?
EVOQUE implant
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
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
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.
Talk to your doctor to see if this trial is right for you
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 NCT04482062 at Clinical Trials.gov.
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References
- Tricuspid valve regurgitation. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/symptoms-causes/syc-20350168.
- 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.
- 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.
- 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.
- 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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