The CLASP II TR trial for tricuspid regurgitation
Patient information
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.
What is tricuspid valve regurgitation?2,3
Tricuspid regurgitation (TR) occurs when the tricuspid valve in your heart doesn't close all the way, allowing blood to flow backwards within the heart. This may cause shortness of breath, swelling in the abdomen, legs, and/or veins in your neck, and can lead to heart failure, if left untreated.
See comparison between healthy heart and one with tricuspid regurgitation
Move the arrow left or right to see comparison
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
What is the Edwards PASCAL system?1
The Edwards PASCAL system is an investigational device designed to repair your tricuspid valve through a minimally invasive procedure called transcatheter tricuspid valve repair. Your doctor will insert through a small puncture in the groin a thin tube through a vein in your leg to reach your heart, and then uses the PASCAL implant to repair your tricuspid valve.
PASCAL implant
PASCAL Ace implant
See how it works
Watch the Edwards PASCAL system procedural animation
What you should know about the CLASP II TR clinical trial
This trial is intended to evaluate the safety and effectiveness of the Edwards PASCAL system with Optimal Medical Therapy (OMT) compared to OMT alone in patients with TR.1, 4
Are you a candidate?4
You may be a candidate for this trial if you are over the age of 18 and are diagnosed with severe and symptomatic tricuspid regurgitation, despite current medical therapy.
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 NCT04097145 at Clinical Trials.gov.
Give us a call
888.713.1564
Send us an email
References
- 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.
Caution: Investigational device
Caution: Investigational device
CAUTION – Investigational device. Limited by Federal (USA) law to investigational use. The device is not available for marketing or commercial sale for the treatment of Tricuspid Regurgitation 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
PP--US-5633 v1.0