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.
See comparison between healthy heart and
one with tricsupid regurgitation
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Tricuspid Regurgitation vs healthy heart
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
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.
- 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
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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