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The CLASP IID/IIF Trial for Mitral Regurgitation

Patient information

dad and two kids
dad and two kids
dad and two kids

References

  1. Data on file. Edwards Lifesciences.
  2. Mitral valve regurgitation. Mayo Clinic. Updated May 17, 2019. Accessed August 24, 2020. https://www.mayoclinic.org/diseases- conditions/mitral-valve-regurgitation/symptoms-causes/syc-20350178.
  3. Mitral valve disease: percutaneous interventions. Cleveland Clinic. Updated May 3, 2019. Accessed August 24, 2020. https://my.clevelandclinic.org/health/treatments/17239-mitral-valve-disease-percutaneous-interventions.
  4. Mitral valve disease. Mayo Clinic. Updated January 7, 2020. Accessed August 24, 2020. https://www.mayoclinic.org/diseases-conditions/mitral-valve-disease/symptoms-causes/syc-20355107.
  5. The CLASP IID/IIF trial: A clinical trial for patients with degenerative mitral regurgitation – patient information guide. Edwards Lifesciences Corporation. 2019.
  6. Edwards PASCAL CLASP IID/IIF pivotal clinical trial protocol (CLASP IID/IIF). ClinicalTrials.gov identifier: NCT03706833. Updated August 13, 2015. Accessed August 24, 2020. https://www.clinicaltrials.gov/ct2/show/NCT 03706833.
  7. 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.
  8. 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.
  9. Edwards PASCAL Transcatheter Valve Repair System: Instructions for Use. Edwards Lifesciences Corporation. May 2020.
  10. The CLASP IID/IIF trial: A clinical trial for patients with functional mitral regurgitation—patient information guide. Edwards Lifesciences Corporation. 2019.

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. See Instructions for Use for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Edwards Lifesciences is the sponsor of the CLASP IID/IIF trial.

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