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 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
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
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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
New medical devices are made available to people on a regular basis. However, before they can be offered to the public, they need to be studied for how safe they are and how well they work.
A clinical trial is a type of research conducted with volunteers that studies specific questions about the safety and effectiveness of medical devices.5
The CLASP II TR clinical trial will evaluate the safety and effectiveness of an investigational device designed to treat TR by repairing the tricuspid valve using a transcatheter procedure (no open heart surgery).
- If selected, you may receive a transcatheter procedure for tricuspid regurgitation
- You will receive one of two therapies, the Edwards PASCAL system, which is under investigation in this study, in conjunction with optimal medical therapy, or optimal medical therapy alone
- This clinical study will allow doctors to understand how the Edwards PASCAL system works in patients like you1
PASCAL implant
Medication
- You will be enrolled randomly in either the Test Group (receiving the Edwards PASCAL system and Optimal Medical Therapy) or the Control Group (receiving only Optimal Medical Therapy).
- You will be monitored throughout the procedure and after implantation of the device. You will need to attend several follow-up visits over a 5-year period
- During the trial, you will have a team of experts—your Heart Team—to guide and support you from beginning to end. You can count on them to answer any questions and work closely with your doctor to provide care1,6
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
Find a trial site near you Download brochure
For more information
We're here for you. If you have questions about the trial, please call the Edwards Patient Support Center at 888-713-1564 or email us at patient_support@edwards.com. For details about the trial, visit www.clinicaltrials.gov and search "NCT04097145".
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. 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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