What is the mechanism of action of this treatment?

The SAPIEN M3 System, a transcatheter mitral valve repair/replacement (TMVR) device, works by replacing the dysfunctional mitral valve with a new valve delivered via a catheter, typically through a minimally invasive approach. This system is designed to restore proper valve function, thereby reducing or eliminating the backflow of blood (regurgitation) into the left atrium. This is crucial for MR patients as it helps to alleviate symptoms such as shortness of breath and fatigue, improves cardiac function, and reduces the risk of heart failure. TMVR is particularly beneficial for patients who are high-risk candidates for traditional open-heart surgery, offering a less invasive alternative with potentially quicker recovery times.

What side effects are associated with this type of intervention?

Common treatments for Mitral Valve Regurgitation include Mitral Valve Repair and Mitral Valve Replacement. The known side effects of these treatments can include bleeding, infection, blood clots, stroke, and complications related to anesthesia. Additionally, patients may experience arrhythmias, valve dysfunction, or failure, and in some cases, there may be a need for reoperation. Specific to transcatheter mitral valve repair/replacement systems like the SAPIEN M3, potential side effects also include vascular complications and device-related issues such as malposition or embolization.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Valve Regurgitation, particularly focusing on transcatheter mitral valve repair (TMVR) systems. One notable FDA-approved device is the MitraClip, which is used for patients with symptomatic primary or secondary mitral regurgitation who are at prohibitive risk for mitral valve surgery. The MitraClip device allows for a minimally invasive procedure to clip together a portion of the mitral valve leaflets to reduce regurgitation. Other treatments include surgical options like mitral valve repair or replacement using mechanical or bioprosthetic valves. The SAPIEN M3 System, currently under study, represents an advancement in TMVR technology, aiming to provide a less invasive alternative to traditional surgical methods.

What other types of research exist?

Promising alternatives to the SAPIEN M3 System for Mitral Valve Regurgitation in 2024 include the MitraClip system, which is a well-established transcatheter mitral valve repair device. Additionally, the Tendyne Transcatheter Mitral Valve Replacement (TMVR) system and the Intrepid TMVR system are emerging as strong contenders, with ongoing clinical trials showing positive outcomes. These alternatives offer minimally invasive options for patients who are at high surgical risk.

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Transcatheter Mitral Valve Repair

SAPIEN M3 System for Mitral Regurgitation (SAPIEN M3 EFS Trial)

N/A

Waitlist Available

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

High risk of cardiovascular surgery

Must not have

Patients with renal insufficiency or receiving renal replacement therapy

Liver disease or significantly abnormal liver function test results

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the safety and effectiveness of the SAPIEN M3 System in patients with severe mitral regurgitation. The device is designed to help the heart valve close properly, preventing blood from flowing backward. The study aims to gather information for future research on this treatment. The SAPIEN M3 System is part of the SAPIEN family of heart valves, which have been used in various applications including aortic and mitral valve replacements.

Who is the study for?

This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.

What is being tested?

The Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.

What are the potential side effects?

While the side effects aren't listed here specifically for the SAPIEN M3 System, similar interventions may include complications like bleeding at the catheter site, infection risks from invasive procedures, potential damage to nearby heart structures during implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am at high risk for heart surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have kidney problems or am on dialysis.

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I have liver disease or abnormal liver test results.

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I am currently pregnant or breastfeeding.

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My condition cannot be treated with surgery.

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I've had surgery on my mitral valve that may interfere with new treatments.

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I have had unexplained blood clots in my veins or lungs more than once.

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I have a blood disorder affecting my white cells, red cells, or platelets.

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I have serious heart artery problems that haven't been treated.

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I have not had active bacterial endocarditis in the last 6 months.

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I cannot take blood thinning medications due to a health condition.

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I haven't been hospitalized for heart failure or needed heart support in the last 30 days.

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I need a heart valve replacement.

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I refuse to receive blood transfusions.

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My heart's right side is not pumping well.

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I have severe, untreatable high blood pressure in my lungs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Technical Success

Secondary study objectives

Reduction in mitral regurgitation (MR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: TMVRExperimental Treatment1 Intervention

Subjects will undergo transcatheter mitral valve replacement

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The SAPIEN M3 System, a transcatheter mitral valve repair/replacement (TMVR) device, works by replacing the dysfunctional mitral valve with a new valve delivered via a catheter, typically through a minimally invasive approach. This system is designed to restore proper valve function, thereby reducing or eliminating the backflow of blood (regurgitation) into the left atrium. This is crucial for MR patients as it helps to alleviate symptoms such as shortness of breath and fatigue, improves cardiac function, and reduces the risk of heart failure. TMVR is particularly beneficial for patients who are high-risk candidates for traditional open-heart surgery, offering a less invasive alternative with potentially quicker recovery times.