Get Treatment for Mitral Regurgitation and Help Others Like You1
If you or a loved one have mitral regurgitation (MR), know you're not alone and you have options when it comes to treatment.
Learn more about this clinical trial
The CLASP IID/IIF clinical trial studies the PASCAL system, a device designed to repair the mitral valve with no open heart surgery.
This trial is meant for patients with mitral regurgitation who are high-risk candidates for open heart surgery. Talk to your doctor to determine if this trial is right for you.
What is Mitral Valve Regurgitation?2
Mitral regurgitation is a condition where the heart’s mitral valve doesn’t close properly, allowing blood to flow backward within the heart. This makes it difficult for your heart to pump enough blood throughout your body. Mitral regurgitation can make you feel tired or short of breath, and can lead to heart failure if left untreated.
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With PASCAL Implant
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Both DMR and FMR may be treated by repairing or replacing the mitral valve. Getting treated for MR could make the difference for your heart and quality of life.1,2,4
What You Should Know About the CLASP IID/IIF Clinical Trial
This trial is intended to evaluate the PASCAL repair system and show it works just as well as a currently available FDA-approved device.6
New medical devices, drugs, vaccines, and other therapies 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 recently developed medications or treatments. If they are considered safe and effective, then they can help patients with all types of health conditions, including mitral regurgitation.7,8
The CLASP IID/IIF clinical trial will evaluate a new device designed to treat MR by repairing the mitral valve using a transcatheter procedure (no open heart surgery).9,10
- A transcatheter procedure will be used to repair your mitral valve in this clinical trial
- You will receive one of two therapies, the PASCAL system, which is under investigation in this study, or MitraClip, a commercially available treatment option6
- This clinical study will allow doctors to understand how the PASCAL repair system works in patients like you
Edwards PASCAL System
- Depending on your diagnosis (DMR or FMR), you will be enrolled in either the CLASP IID or CLASP IIF group5,10
- Your health will be monitored throughout the clinical trial and after implantation of the device. This will require you to come in for several follow-up visits over a 5-year period6
- 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
Regardless of which group you are assigned, you will be treated for MR through a minimally invasive transcatheter procedure.1
- The costs of tests and procedures conducted during the clinical trial will be covered by Edwards Lifesciences, the sponsor of this study
- You will still be responsible for the cost of your usual ongoing medical care, including deductibles and co-payments that would be billed to you or your health insurance provider
Are You a Candidate?1
You may be eligible for this trial if you meet these key criteria:
- You are eighteen (18) years of age or older
- You have severe degenerative mitral regurgitation and are considered prohibitive risk for mitral valve surgery by your Heart Team
- You have severe functional mitral regurgitation with stable heart failure medications as determined by your Heart Team
- Data on file. Edwards Lifesciences.
- 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.
- 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.
- 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.
- The CLASP IID/IIF trial: A clinical trial for patients with degenerative mitral regurgitation – patient information guide. Edwards Lifesciences Corporation. 2019.
- 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.
- 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.
- 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.
- Edwards PASCAL Transcatheter Valve Repair System: Instructions for Use. Edwards Lifesciences Corporation. May 2020.
- 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.
Edwards, Edwards Lifesciences, the stylized E logo, and PASCAL are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners
© 2020 Edwards Lifesciences Corporation. All rights reserved. PP--US-5277 v1.0
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