Learn more about this clinical trial1
The CLASP II TR clinical trial study is to determine the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System, a device designed to repair the tricuspid valve with no open heart surgery.
This trial is meant for patients with severe, symptomatic tricuspid regurgitation, despite current medical therapy.
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
PASCAL implant vs healthy heart
Severe or symptomatic TR may be treated by repairing or replacing the tricuspid valve. Getting treated for TR could make a difference for your heart and quality of life.1,2,3
The Edwards PASCAL Transcatheter Valve Repair System
- CLASP II TR Pivotal Clinical Trial Information and Informed Consent Form. Edwards Lifesciences Corporation. June 2020.
- Tricuspid valve regurgitation - Symptoms & causes. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/symptoms-causes/syc-20350168.
- Tricuspid valve regurgitation - Diagnosis & treatment. Mayo Clinic. Accessed January 9, 2021. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/diagnosis-treatment/drc-20350173.
- 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.
- 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.
- 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 (United States) law to investigational use only.
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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