What side effects are associated with this type of intervention?

Common side effects of transcatheter mitral valve replacement (TMVR) or repair include bleeding, infection, arrhythmias, and vascular complications at the catheter insertion site. Other potential risks are valve dysfunction or failure, stroke, and the need for a pacemaker. These procedures may also lead to complications such as mitral stenosis or regurgitation if the valve does not function properly post-implantation.

What prior FDA approvals exist?

The FDA has approved several transcatheter devices for the treatment of Mitral Valve Regurgitation. Notably, the MitraClip device, which allows for transcatheter mitral valve repair, was approved for patients with symptomatic primary or secondary mitral regurgitation who are at prohibitive risk for surgery. Additionally, the Tendyne Transcatheter Mitral Valve Replacement (TMVR) system has been approved for patients with severe mitral regurgitation who are not candidates for conventional surgery. These devices offer less invasive alternatives to open-heart surgery, similar to the investigational Cephea Mitral Valve System.

What other types of research exist?

Promising novel alternatives to the Cephea Mitral Valve System for treating mitral valve regurgitation in 2024 include the MitraClip system, which is a well-established transcatheter mitral valve repair device, and the Tendyne Transcatheter Mitral Valve Implantation (TMVI) system, which has shown positive outcomes in clinical trials. Another emerging option is the PASCAL transcatheter valve repair system, which offers a minimally invasive approach with promising early results. These alternatives provide various options for patients who are not candidates for open-heart surgery.

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Mitral Valve System

Cephea Valve System for Mitral Regurgitation

N/A

Recruiting

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

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

Must have

Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria

Be older than 18 years old

Must not have

Need for emergent or urgent surgery.

Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days post implant

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new device called the Cephea Mitral Valve System that can fix or replace a damaged heart valve using a thin tube. It aims to help patients with mitral valve disease who need a less invasive treatment than open-heart surgery. The Cephea Mitral Valve System is a new technology developed by Cephea Valve Technologies, aiming to treat severe mitral regurgitation through a less invasive approach.

Who is the study for?

This trial is for patients with severe mitral valve regurgitation (a heart valve problem) who are symptomatic and have a left ventricular ejection fraction (LVEF) of at least 30%. It's aimed at those for whom a non-surgical, catheter-based approach is better than open-heart surgery. Patients who've had previous treatments that could affect the new valve can't participate.

What is being tested?

The Cephea Mitral Valve System is being tested to see if it's safe and effective in treating severe mitral regurgitation without needing open-heart surgery. The study involves placing this device into the heart through a catheter to help control blood flow.

What are the potential side effects?

While specific side effects aren't listed, similar procedures may include risks like bleeding, infection, damage to the heart or vessels, irregular heartbeats, stroke, or need for additional surgeries.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have severe mitral valve disease with significant regurgitation or narrowing.

Exclusion Criteria

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

Select...

I need surgery as soon as possible.

Select...

I've had surgery that affects heart valve replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days post implant for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

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 of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

0 / 3Eligibility 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) is commonly treated through surgical or transcatheter interventions. Transcatheter mitral valve replacement (TMVR) and repair are minimally invasive procedures that aim to restore proper valve function. TMVR involves replacing the damaged mitral valve with a prosthetic valve via a catheter, which helps to prevent the backflow of blood into the left atrium. Transcatheter mitral valve repair, on the other hand, typically involves techniques such as edge-to-edge repair (e.g., MitraClip) to improve valve coaptation and reduce regurgitation. These treatments are crucial for MVR patients as they offer less invasive options compared to open-heart surgery, potentially reducing recovery time and associated risks, while effectively managing symptoms and improving quality of life.