The CLASP II TR trial for tricuspid regurgitation
Patient information
Learn more about this clinical trial1
The goal of the CLASP II TR clinical trial 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 symptomatic severe tricuspid regurgitation.
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 the comparison between a healthy heart and one with tricuspid regurgitation
Move the arrow left or right to see the comparison
PASCAL implant vs healthy heart
Symptomatic severe 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. In this procedure, a catheter (small plastic tube) is inserted through a small puncture in the groin via a vein leading directly to the heart. A flexible catheter will then be tracked through the vessel to deliver the PASCAL device to the tricuspid valve. The PASCAL device is secured to the leaflets of the 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 symptomatic severe tricuspid regurgitation.
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.
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888.713.1564
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References
- CLASP II TR Pivotal Clinical Trial Information and Informed Consent Form. Edwards Lifesciences Corporation. June 2020.
- Tricuspid Regurgitation Symptoms and causes - Mayo Clinic. Update on April 6, 2022. Accessed June 20, 2023. https://www.mayoclinic.org/diseases-conditions/tricuspid-valve-regurgitation/symptoms-causes/syc-20350168.
- Tricuspid Regurgitation Diagnosis and treatment - Mayo Clinic. Updated on April 6, 2022. Accessed June 20, 2023. 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 June 2, 2023. Accessed June 13, 2023. https://clinicaltrials.gov/ct2/show/NCT04097145.
- Clinical Trials_What Patients Need to Know_FDA - S-9679 (Content current as of Jan 4, 2018) Accessed on May 26, 2023. https://www.fda.gov/patients/clinical-trials-what-patients-need-know.
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
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