What side effects are associated with this type of intervention?

Common treatments for Mitral Valve Regurgitation, particularly those similar to the SAPIEN M3 System (Transcatheter Mitral Valve Replacement), include surgical mitral valve repair or replacement and other transcatheter mitral valve interventions. Known side effects of these treatments can include bleeding, infection, thromboembolic events, valve dysfunction or failure, and complications related to the access site such as vascular injury. Additionally, patients may experience arrhythmias, heart block requiring pacemaker implantation, and in rare cases, stroke or myocardial infarction.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Valve Regurgitation, particularly focusing on transcatheter approaches. One notable approval is the MitraClip, a transcatheter mitral valve repair device that clips together a portion of the mitral valve leaflets to reduce regurgitation. This device is often used in patients who are at high risk for traditional open-heart surgery. The SAPIEN M3 System, currently under trial, represents a similar transcatheter approach but focuses on valve replacement rather than repair, offering a minimally invasive option for patients with significant mitral regurgitation who are unsuitable for conventional surgical treatments.

What other types of research exist?

Promising novel alternatives to the SAPIEN M3 System for treating mitral valve regurgitation in 2024 include the Tendyne Transcatheter Mitral Valve Replacement System, the Intrepid TMVR System, and the CardiAQ-Edwards TMVR System. These devices have shown positive outcomes in clinical trials and are considered effective options for patients unsuitable for traditional surgical treatments.

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Heart Valve Replacement

SAPIEN M3 System for Mitral Valve Regurgitation (ENCIRCLE Trial)

N/A

Recruiting

Led By John Webb, MD

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

NYHA functional class ≥ II

Must not have

Female who is pregnant or lactating

Inability to tolerate or a medical condition precluding treatment with antithrombotic therapy, including heparin administration during the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

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 who can't use other treatments. The device helps the heart valve close properly to stop it from leaking. The SAPIEN transcatheter heart valve (THV) has been previously tested and shown to be safe and effective in the pulmonary position.

Who is the study for?

The ENCIRCLE Trial is for adults with severe mitral valve regurgitation who can't have standard surgery or other transcatheter treatments. They must be stable after heart failure management and not pregnant, in another trial, or have conditions like recent heart attacks, untreated coronary disease, certain anatomy issues, severe lung problems, or life expectancy under a year.

What is being tested?

This study tests the SAPIEN M3 System's safety and effectiveness for patients with symptomatic mitral regurgitation deemed unsuitable for other treatments. Participants will receive the SAPIEN M3 valve and dock to correct their condition.

What are the potential side effects?

While specific side effects are not listed here, similar procedures may include risks such as bleeding, infection at the catheter insertion site, damage to blood vessels or the heart itself during implantation of the device.

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 have some limitations on physical activity due to heart problems.

Exclusion Criteria

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

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I am currently pregnant or breastfeeding.

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

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

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I have had a heart transplant.

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I currently have or had COVID-19 with lasting effects.

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I refuse to receive blood transfusions.

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

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I have a history of blood disorders or abnormal bleeding.

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My heart's structure prevents the use of a specific heart valve treatment.

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I need surgery on my heart valve within a year.

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I am scheduled for surgery within the next year.

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I am currently taking antibiotics for an infection.

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My body's structure doesn't allow for certain heart valve procedures.

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I haven't needed heart support machines or drugs in the last 30 days.

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My heart's right side is not pumping well.

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I need home oxygen or take daily oral steroids for my lung condition.

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I have kidney problems or am on dialysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Non-hierarchical composite of death and heart failure rehospitalization

Secondary study objectives

Decrease in LVEDVi compared to baseline

Improvement in KCCQ Overall Score compared to baseline

Improvement in MR compared to baseline

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: TMVR - Main CohortExperimental Treatment1 Intervention

Subjects for whom commercially available surgical or transcatheter treatment options are deemed unsuitable will have transcatheter mitral valve replacement (TMVR).

Group II: TMVR - MAC RegistryExperimental Treatment1 Intervention

Subjects with mitral annular calcification (MAC) will have TMVR.

Group III: TMVR - Failed TEER RegistryExperimental Treatment1 Intervention

Subjects who have had an attempted but failed transcatheter edge-to-edge repair (TEER) procedure will have TMVR.

0 / 19Eligibility 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

Transcatheter Mitral Valve Replacement (TMVR), such as the SAPIEN M3 System, involves the insertion of a new valve via a catheter, which is threaded through the blood vessels to the heart. This minimally invasive procedure replaces the faulty mitral valve without the need for open-heart surgery. The new valve helps to restore proper blood flow and reduce regurgitation by ensuring the mitral valve closes tightly. This is crucial for MR patients as it alleviates symptoms, improves heart function, and reduces the risk of complications such as heart failure. Other common treatments include surgical valve repair or replacement and medical management to control symptoms and prevent further heart damage.