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The CLASP II TR trial for tricuspid regurgitation

Patient information

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References

  1. CLASP II TR Pivotal Clinical Trial Information and Informed Consent Form. Edwards Lifesciences Corporation. June 2020.
  2. Tricuspid valve regurgitation - Symptoms & causes. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/symptoms-causes/syc-20350168.
  3. Tricuspid valve regurgitation - Diagnosis & treatment. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/diagnosis-treatment/drc-20350173.
  4. Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR). ClinicalTrials.gov identifier: NCT04097145. Updated August 12, 2020. Accessed January 8, 2021. https://clinicaltrials.gov/ct2/show/NCT04097145.
  5. Clinical trials: what patients need to know. US Food and Drug Administration. Updated January 4, 2018. Accessed August 24, 2020. https://www.fda.gov/drugs/information-consumers-and-patients-drugs/inside-clinical-trials-testing-medical-products-people.
  6. CLASP II TR Pivotal Clinical Trial - Clinical Protocol - Version B. Edwards Lifesciences Corporation. July 30, 2020.

Important safety information

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

Edwards Lifesciences is the sponsor of the CLASP II TR trial.

Edwards, Edwards Lifesciences, the stylized E logo, CLASP, and PASCAL are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners

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