What side effects are associated with this type of intervention?

Common side effects of Transcatheter Mitral Valve Replacement (TMVR) procedures, such as those involving the Twelve TMVR System and the Medtronic Intrepid™ TMVR System, include bleeding, infection, and vascular complications at the catheter insertion site. Other potential risks are stroke, arrhythmias, and valve dysfunction or displacement. Additionally, patients may experience complications related to anesthesia and contrast dye used during the procedure. It is important to discuss these risks with a healthcare provider to understand the potential benefits and drawbacks of TMVR.

What prior FDA approvals exist?

The FDA has approved several transcatheter mitral valve replacement (TMVR) systems for the treatment of mitral valve regurgitation, which are similar to the Twelve TMVR System and the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System currently under study. These systems are designed to provide a minimally invasive alternative to traditional surgical mitral valve repair or replacement, particularly for high-risk patients. The MitraClip, for example, is a well-known FDA-approved device that allows for the percutaneous repair of the mitral valve. While specific FDA approvals for the Twelve TMVR System and Medtronic Intrepid™ are not detailed, these systems represent the ongoing advancements in TMVR technology aimed at improving outcomes for patients with severe mitral regurgitation.

What other types of research exist?

Promising novel alternatives to the Twelve TMVR System and Medtronic Intrepid™ TMVR System for mitral valve regurgitation patients include the Edwards Lifesciences' Pascal Transcatheter Valve Repair System and Abbott's Tendyne Transcatheter Mitral Valve Implantation (TMVI) System. Both have shown encouraging results in clinical trials and are considered potential options for patients seeking treatment in 2024.

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Transcatheter Mitral Valve Replacement System

Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

N/A

Waitlist Available

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

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

Must have

Severe mitral regurgitation (MR Grade 3-4+)

Symptomatic mitral regurgitation (NYHA Class II-IV)

Must not have

Renal insufficiency (Creatinine > 2.5 mg/dL)

Prior valve surgery or need for other valve surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new devices that replace a leaky heart valve without major surgery. It targets high-risk patients who can't undergo traditional surgery. The devices are inserted through a small tube to fix the valve.

Who is the study for?

This trial is for very high-risk patients with severe, symptomatic mitral valve regurgitation (MR Grade 3-4+), specifically those who can undergo a transcatheter procedure. Participants must have a heart structure that fits the TMVR system and not have had recent strokes, heart attacks, or other valve surgeries.

What is being tested?

The study tests two versions of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System: one via trans-apical access (PILOT) and another through transfemoral transseptal access (EFS). It aims to assess their safety and performance in treating severe mitral regurgitation.

What are the potential side effects?

Potential side effects may include complications related to heart procedures such as bleeding, blood vessel damage, irregular heartbeats, infection risk at the incision site, stroke risks due to clots or device malfunction.

Eligibility Criteria

Inclusion Criteria

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

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I have severe leakage in my heart's mitral valve.

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I have symptoms of heart valve issues causing shortness of breath or fatigue.

Exclusion Criteria

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

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My kidney function is impaired with high creatinine levels.

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I have had or need surgery for a heart valve problem.

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I need a procedure to improve blood flow to my heart.

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I have not had a heart attack in the last 6 months.

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I have had or currently have endocarditis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 5 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

Adverse Events

Secondary study objectives

Procedural Success (Number of patients with successful TMVR placement)

Reduction of MR (Number of patients with a reduction of MR Grade)

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: Transcatheter Mitral Valve Replacement (TMVR) ImplantExperimental Treatment2 Interventions

Twelve TMVR Implant

0 / 7Eligibility 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) systems, such as the Twelve TMVR System and the Medtronic Intrepid™ TMVR System, replace the malfunctioning mitral valve via a catheter-based approach, avoiding open-heart surgery. The new valve is delivered through a vein and positioned to take over the function of the damaged valve, ensuring proper blood flow from the left atrium to the left ventricle. This treatment is vital for Mitral Valve Regurgitation patients as it restores normal heart function, alleviates symptoms, and enhances quality of life.

Recent advances in patient selection and devices for transcatheter edge-to-edge mitral valve repair in heart failure.