The CLASP IID/IIF Trial for Mitral Regurgitation
Patient information
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.
Understand the two types of MR
Degenerative mitral regurgitation3-5
Degenerative mitral regurgitation (DMR), also known as primary mitral regurgitation, usually occurs due to a structural problem with the valve’s leaflets.
Functional mitral regurgitation3,4
Functional mitral regurgitation (FMR), also known as secondary mitral regurgitation, occurs when the valve has been stretched and its leaflets don’t close tightly.
Move the arrow left or right to see comparison
FMR vs healthy heart
With PASCAL implant vs healthy heart
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
The Edwards PASCAL transcatheter valve repair system
What is the PASCAL repair system?1-3
PASCAL implant
The Edwards PASCAL repair system is designed to repair your mitral valve through a minimally invasive procedure called transcatheter mitral valve repair. Your doctor places a thin tube through a vein in your leg to reach your heart, and then uses the PASCAL implant to repair your mitral valve.
PASCAL implant
See how it works
Watch the PASCAL repair system procedural animation
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
Are you a candidate?1
You may be eligible for this trial if you meet these key criteria:
- 1You are eighteen (18) years of age or olderand
- 2You have severe degenerative mitral regurgitation and are considered prohibitive risk for mitral valve surgery by your Heart Teamor
- 3You have severe functional mitral regurgitation with stable heart failure medications as determined by your Heart Team
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 NCT03706833 at Clinical Trials.gov.
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References
- 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
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
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