What Are The Indications For Mitral Valve Recurgitation Repair

Get Treatment for Mitral Regurgitation and Help Others Similar Y'allⁱ

If you or a loved one have mitral regurgitation (MR), know you're not lone and you have options when it comes to treatment.

Learn more well-nigh this clinical trial

The CLASP IID/IIF clinical trial studies the PASCAL system, a device designed to repair the mitral valve with no open up heart surgery.

This trial is meant for patients with mitral regurgitation who are loftier-risk candidates for open heart surgery. Talk to your doctor to make up one's mind if this trial is right for y'all.

What is Mitral Valve Regurgitation?²

Mitral regurgitation is a condition where the heart's mitral valve doesn't shut properly, allowing blood to catamenia astern within the middle. This makes information technology hard for your middle to pump enough blood throughout your trunk. Mitral regurgitation tin can brand yous feel tired or short of breath, and can atomic number 82 to centre failure if left untreated.

Understand the Two Types of MR

Degenerative mitral regurgitation^3-v

Degenerative mitral regurgitation (DMR), also known as chief mitral regurgitation, usually occurs due to a structural problem with the valve'due south leaflets.

Functional mitral regurgitation^iii,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 correct to see comparing

DMR
vs healthy heart

FMR
vs healthy heart

With PASCAL Implant
vs salubrious heart

Both DMR and FMR may be treated past repairing or replacing the mitral valve. Getting treated for MR could make the difference for your heart and quality of life.^ane,2,4

What is the PASCAL repair system?^ane-iii

The Edwards PASCAL repair system is designed to repair your mitral valve through a minimally invasive process called transcatheter mitral valve repair. Your physician places a thin tube through a vein in your leg to reach your center, so 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 organisation and show information technology works just as well equally a currently available FDA-canonical device.⁶

New medical devices, drugs, vaccines, and other therapies are fabricated bachelor to people on a regular basis. However, before they can be offered to the public, they demand to be studied for how safe they are and how well they piece of 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 assistance patients with all types of health conditions, including mitral regurgitation.^seven,eight

The CLASP IID/IIF clinical trial will evaluate a new device designed to treat MR past repairing the mitral valve using a transcatheter procedure (no open up heart surgery).^9,10

• A transcatheter procedure will be used to repair your mitral valve in this clinical trial
• You will receive one of 2 therapies, the PASCAL system, which is under investigation in this written report, or MitraClip, a commercially available treatment option⁶
• This clinical study will let doctors to sympathise how the PASCAL repair system works in patients similar you

Edwards PASCAL Arrangement

MitraClip
Organization

• Depending on your diagnosis (DMR or FMR), you volition be enrolled in either the Clasp IID or CLASP IIF group^v,x
• Your health volition exist monitored throughout the clinical trial and subsequently implantation of the device. This will crave you to come up in for several follow-up visits over a 5-year flow⁶
• During the trial, you volition accept a squad of experts—your Heart Team—to guide and support you from get-go to terminate. You tin can count on them to answer whatever questions and piece of work closely with your doctor to provide care^{ane,half dozen}

Regardless of which group you are assigned, y'all will be treated for MR through a minimally invasive transcatheter process.¹

Are You a Candidate?ⁱ

You lot may be eligible for this trial if you run into these key criteria:

1. You are eighteen (18) years of age or older

   and

2. You have astringent degenerative mitral regurgitation and are considered prohibitive chance for mitral valve surgery by your Heart Team

   or

3. You accept severe functional mitral regurgitation with stable heart failure medications as determined by your Middle Squad

We're here for you lot

We are committed to providing the highest levels of client service to assistance our patients ameliorate their quality of life. For any questions, please contact the Edwards Patient Back up Center. For details near the trial, visit
NCT03706833at Clinical Trials.gov.

References:

1. Data on file. Edwards Lifesciences.
2. Mitral valve regurgitation. Mayo Clinic. Updated May 17, 2022. Accessed Baronial 24, 2022. https://www.mayoclinic.org/diseases- weather/mitral-valve-regurgitation/symptoms-causes/syc-20350178.
3. Mitral valve affliction: percutaneous interventions. Cleveland Clinic. Updated May 3, 2022. Accessed Baronial 24, 2022. https://my.clevelandclinic.org/health/treatments/17239-mitral-valve-disease-percutaneous-interventions.
4. Mitral valve illness. Mayo Clinic. Updated January vii, 2022. Accessed Baronial 24, 2022. https://www.mayoclinic.org/diseases-weather condition/mitral-valve-disease/symptoms-causes/syc-20355107.
5. The Clasp IID/IIF trial: A clinical trial for patients with degenerative mitral regurgitation – patient information guide. Edwards Lifesciences Corporation. 2022.
6. Edwards PASCAL CLASP IID/IIF pivotal clinical trial protocol (CLASP IID/IIF). ClinicalTrials.gov identifier: NCT03706833. Updated August 13, 2022. Accessed August 24, 2022. https://www.clinicaltrials.gov/ct2/testify/NCT 03706833.
7. Clinical trials: what patients need to know. U.s. Food and Drug Administration. Updated January 4, 2022. Accessed August 24, 2022. https://www.fda.gov/patients/ clinical-trials-what-patients-need-know.
8. Inside Clinical Trials: Testing Medical Products in People. US Nutrient and Drug Administration. Updated Nov half-dozen, 2022. Accessed August 25, 2022. https://www.fda.gov/drugs/drug- information-consumers/inside-clinical-trials-testing-medical-products-people.
9. Edwards PASCAL Transcatheter Valve Repair System: Instructions for Utilize. Edwards Lifesciences Corporation. May 2022.
10. The CLASP IID/IIF trial: A clinical trial for patients with functional mitral regurgitation—patient information guide. Edwards Lifesciences Corporation. 2022.

Important prophylactic data

Of import prophylactic information

Circumspection – Investigational device. Express by Federal (or U.s.a.) law to investigational use. This device is not available for marketing or commercial sale in the The states. Run into Instructions for Utilise 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 corresponding owners

© 2022 Edwards Lifesciences Corporation. All rights reserved. PP--U.s.-5277 v1.0

Source: https://www.edwards.com/pages/MRTrials

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