What side effects are associated with this type of intervention?

Common treatments for Mitral Valve Regurgitation (MR) include surgical repair, mitral valve replacement, and percutaneous therapies such as the MitraClip device. Known side effects of these treatments can include bleeding, infection, arrhythmias, thromboembolism, and complications related to anesthesia. Specifically, for percutaneous therapies like the MitraClip, potential side effects also include vascular complications at the access site and device-related issues such as partial clip detachment or single leaflet device attachment.

What prior FDA approvals exist?

The FDA has approved the MitraClip device for the treatment of severe degenerative mitral regurgitation in patients who are considered high risk for surgical repair or replacement. The MitraClip device works by physically repairing the mitral valve to prevent regurgitation, similar to the approach being studied in the CardioMech Mitral Valve Repair System trial.

What other types of research exist?

Promising novel alternatives to the CardioMech Mitral Valve Repair System for mitral valve regurgitation patients in 2024 include: 1) Transcatheter Mitral Valve Repair (TMVR) techniques, such as the MitraClip, which allows for edge-to-edge repair via a catheter-based approach. 2) Transcatheter Mitral Valve Replacement (TMVR), which involves replacing the mitral valve using a catheter-based method, offering a less invasive option compared to traditional surgery. 3) Neo-chordae implantation, a technique that involves the percutaneous placement of artificial chordae tendineae to support the mitral valve leaflets. These alternatives provide effective treatment options for patients who are at high risk for conventional surgery.

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Mitral Valve Repair System

CardioMech MVRS for Mitral Valve Regurgitation

N/A

Recruiting

Led By Mayra Guerrero, MD

Research Sponsored by CardioMech AS

Eligibility Criteria Checklist

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

Must have

Intermediate or high surgical risk for mitral valve repair

Eighteen (18) years of age or greater

Must not have

History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device

History of rheumatic heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the CardioMech Mitral Valve Repair System (MVRS) to help patients with a leaky heart valve who are at high risk for surgery. The device aims to fix the valve and improve heart function without needing open-heart surgery. The HARPOON Beating Heart Mitral Valve Repair System (MVRS) has shown it can safely and effectively repair the heart valve while the heart is still beating.

Who is the study for?

This trial is for adults with moderate to severe mitral valve regurgitation due to prolapse or flail, who are at intermediate or high risk for surgical repair. It's not suitable for those with a history of heart infections, previous mitral valve surgeries, rheumatic heart disease, severely calcified leaflets that prevent device placement, or complex MR mechanisms.

What is being tested?

The CardioMech Mitral Valve Repair System (MVRS) is being tested in this trial. The MVRS aims to safely and effectively treat degenerative mitral valve regurgitation without the need for traditional surgery.

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include complications related to device implantation such as bleeding, infection at the site of insertion, potential damage to surrounding structures during deployment and possible need for future surgeries.

Eligibility Criteria

Inclusion Criteria

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

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I am at a moderate to high risk for complications from mitral valve surgery.

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I am 18 years old or older.

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My heart valve leaks severely due to a prolapse or flail.

Exclusion Criteria

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

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I have had surgery on my heart's mitral valve or a device installed in my heart.

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I have had rheumatic heart disease.

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I have had endocarditis before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: CardioMech Mitral Valve Repair System (MVRS)Experimental Treatment1 Intervention

0 / 6Eligibility 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 most common treatments for Mitral Valve Regurgitation (MR) include medical therapy, surgical repair, and percutaneous interventions. The CardioMech Mitral Valve Repair System, a percutaneous approach, physically repairs the mitral valve to prevent regurgitation by improving valve coaptation and reducing the backflow of blood into the left atrium. This is crucial for MR patients as it helps alleviate symptoms, prevents the progression of heart failure, and improves overall cardiac function. By addressing the structural issues of the valve, these treatments aim to restore normal hemodynamics and enhance the patient's quality of life.

Mitral Valve Disease: a Comprehensive Review.The Role of Medical Therapy in Moderate to Severe Degenerative Mitral Regurgitation.Preoperative evaluation before MitraClip®: present and future perspective.