What side effects are associated with this type of intervention?

Common side effects of mitral valve replacement treatments for Mitral Valve Regurgitation include bleeding, infection, blood clots, and stroke. Patients may also experience complications related to the prosthetic valve, such as valve malfunction or degeneration, as well as arrhythmias, heart failure, and anesthesia-related issues. These side effects are pertinent to both traditional surgical and newer transcatheter mitral valve replacement procedures.

What prior FDA approvals exist?

The FDA has approved several treatments for Mitral Valve Regurgitation, particularly focusing on mitral valve replacement. Traditional surgical options include mechanical and bioprosthetic valve replacements, which have been standard treatments for many years. More recently, transcatheter mitral valve replacement (TMVR) systems, such as the MitraClip, have gained approval for patients who are at high surgical risk. These minimally invasive procedures aim to restore normal valve function by replacing the damaged or diseased mitral valve, similar to the goals of the Innovalve mitral valve replacement system currently under study.

What other types of research exist?

Promising novel alternatives to the Innovalve mitral valve replacement system for Mitral Valve Regurgitation patients in 2024 include: 1) Transcatheter Mitral Valve Repair (TMVR) systems such as the MitraClip, which allows for minimally invasive repair of the mitral valve. 2) The PASCAL system, another TMVR device that has shown positive outcomes in clinical trials. 3) The Tendyne Transcatheter Mitral Valve Implantation (TMVI) system, which is designed for patients with severe MR who are at high surgical risk. These alternatives offer less invasive options with promising efficacy and safety profiles.

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Mitral Valve Replacement System

Innovalve Artificial Mitral Valve for Mitral Valve Regurgitation (TWIST-EFS Trial)

Phase 1

Recruiting

Research Sponsored by Innovalve Bio Medical Ltd.

Eligibility Criteria Checklist

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

Must have

High risk for open-heart surgery

Clinically significant, symptomatic mitral regurgitation

Must not have

Unsuitable anatomy

Patient is inoperable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Summary

This trial is testing a new device called the Innovalve mitral valve replacement system. It is designed for patients who need their mitral valve replaced due to severe damage. The device works by taking over the function of the damaged valve to ensure proper blood flow in the heart.

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. Participants must meet specific anatomical criteria and have a heart's ejection fraction (EF) of more than 25%.

What is being tested?

The study is testing the Innovalve MR system, which is a new device designed to replace the mitral valve in the heart without needing open-heart surgery. The focus is on assessing its safety and how well it works.

What are the potential side effects?

While not explicitly listed, side effects may include typical risks associated with heart procedures such as bleeding, infection, or issues related to device placement like blood clots or improper valve function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am considered high risk for open-heart surgery.

Select...

I have serious symptoms from mitral valve leakage.

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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absence of implant or delivery related serious adverse events at 30 days

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

MV replacement with Innovalve MR 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) is commonly treated through medical management, surgical repair, or valve replacement. Medical management includes the use of medications such as diuretics, beta-blockers, and ACE inhibitors to reduce symptoms and manage heart failure. Surgical repair involves techniques like annuloplasty to tighten or reinforce the valve. Valve replacement, such as with the Innovalve mitral valve replacement system, involves replacing the damaged or diseased valve with a prosthetic one to restore normal valve function. This is crucial for MVR patients as it can significantly improve symptoms, prevent heart failure progression, and enhance overall quality of life.