What side effects are associated with this type of intervention?

Mitral valve replacement, including systems like the Edwards EVOQUE Eos, is a common treatment for severe mitral valve regurgitation. Known side effects of mitral valve replacement can include bleeding, infection, blood clots, and valve dysfunction or failure. Patients may also experience complications related to anesthesia, arrhythmias, and in some cases, stroke. Long-term risks include the potential need for reoperation and issues related to the durability of the prosthetic valve.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Valve Regurgitation, particularly focusing on mitral valve replacement devices. 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. Additionally, surgical mitral valve replacement options include mechanical and bioprosthetic valves, which are used to replace the damaged mitral valve entirely. These treatments aim to restore proper valve function and improve patient outcomes, similar to the objectives of the Edwards EVOQUE Eos mitral valve replacement system currently under study.

What other types of research exist?

Promising alternatives to the Edwards EVOQUE Eos mitral valve replacement system for mitral valve regurgitation patients in 2024 include: 1) The MitraClip system, which is a minimally invasive transcatheter mitral valve repair device. 2) The Tendyne Transcatheter Mitral Valve Implantation (TMVI) system, which offers a less invasive option for patients who are not candidates for traditional surgery. 3) The PASCAL transcatheter valve repair system, which provides another minimally invasive option for mitral valve repair. These alternatives have shown positive outcomes in clinical trials and are gaining traction as viable options for patients with mitral valve regurgitation.

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Mitral Valve Replacement System

Mitral Valve Replacement for Mitral Valve Regurgitation

N/A

Waitlist Available

Led By Rajendra Makkar, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

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

Must have

Clinically significant, symptomatic mitral regurgitation

High risk for open-heart surgery

Must not have

Unsuitable anatomy

Patient is inoperable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device that replaces a damaged heart valve in patients whose mitral valve is not working properly. The new valve helps the heart pump blood more effectively. The Evalve Mitraclip, a device for percutaneous mitral valve repair, is currently being tested.

Who is the study for?

This trial is for individuals with severe, symptomatic mitral valve regurgitation who are at high risk for open-heart surgery but meet specific anatomical criteria. It's not suitable for those considered inoperable or with unsuitable anatomy.

What is being tested?

The study is testing the Edwards EVOQUE Eos Mitral Valve Replacement System to assess its safety and performance as a treatment option for mitral valve regurgitation.

What are the potential side effects?

Potential side effects of the procedure may include bleeding, infection, blood clots, heart rhythm problems, stroke, or device malfunction. Specific side effects will depend on individual patient factors.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have serious symptoms from a leaky heart valve.

Select...

I am considered high risk for open-heart surgery.

Exclusion Criteria

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

Select...

My body's structure makes me ineligible for the procedure.

Select...

My condition cannot be treated with surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days, 6 months, 12 months, annual for five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days, 6 months, 12 months, annual for five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days, 6 months, 12 months, annual for five years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Composite of major adverse events

Secondary study objectives

Clinical Success

Device Success

NYHA functional class

+3 more

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: TreatmentExperimental Treatment1 Intervention

Treatment with the Edwards EVOQUE Eos mitral valve replacement system

0 / 4Eligibility 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

Mitral Valve Regurgitation (MVR) treatments include medical management, surgical repair, and mitral valve replacement. Medical management uses medications to alleviate symptoms and reduce heart strain. Surgical repair involves techniques like annuloplasty to fix the existing valve. Mitral valve replacement, such as with the Edwards EVOQUE Eos system, replaces the damaged valve with a prosthetic one, restoring proper valve function and preventing backward blood flow. This is crucial for patients with severe regurgitation, as it improves cardiac function and quality of life.