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Mitral Valve Repair Device

Epicardial Device Implant for Mitral Regurgitation (ENRAPTUS Trial)

N/A

Waitlist Available

Led By Robert L Smith II, MD

Research Sponsored by Mitre Medical Corp.

Eligibility Criteria Checklist

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

Must have

Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States

Patient is 22 years of age or older

Must not have

NY heart class IV

Contraindication to cardiopulmonary bypass (CPB)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure through 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trialstudies a heart surgery device to help with mitral insufficiency in patients with moderate to severe ischemia or functional mitral regurgitation.

Who is the study for?

This trial is for adults over 22 with moderate to severe ischemic or functional mitral regurgitation who are stable on heart failure therapy and scheduled for cardiac surgery. Exclusions include very weak heart function, advanced heart failure symptoms, large mitral valves, pregnancy, certain kidney issues, abnormal cardiac anatomy, prior valve interventions, and more.

What is being tested?

The trial tests the Mitral Touch System's safety and performance in reshaping the mitral valve annulus during cardiac surgery. It aims to treat patients with significant mitral insufficiency through either a sternotomy or thoracotomy approach.

What are the potential side effects?

Potential side effects may include complications from implanting the device such as infection risk at surgical site, bleeding complications due to surgery or cardiopulmonary bypass (CPB), potential damage to surrounding heart structures during implantation.

Eligibility Criteria

Inclusion Criteria

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

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I have been on a stable heart failure treatment for the last 90 days.

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I am 22 years old or older.

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My heart valve leak was rated moderate or severe on an echo test.

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I am scheduled for heart surgery.

Exclusion Criteria

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

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My heart condition severely limits my physical activity.

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I cannot undergo procedures that require stopping my heart and lungs.

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I have scar tissue around my heart.

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My heart valve condition didn't improve after a procedure.

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I have a heart condition I was born with, but it's not PFO or ASD.

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I am not pregnant, confirmed by a test or my menstrual history.

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I have been found to have an abnormal heart structure before or during surgery.

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My kidney function is low (eGFR below 30).

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I am showing signs of a failing heart.

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I have a structural problem with my mitral valve.

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I have had endocarditis before or have it now.

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I have liver cirrhosis or my liver is not functioning properly.

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I have had surgery or a less invasive procedure on my mitral valve.

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I am on long-term IV medication to strengthen my heart.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~procedure

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

Treatment Details

Study Objectives

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

Primary study objectives

Rate of Freedom from Major Adverse Events

Secondary study objectives

Rate of Freedom from Serious Adverse Events from Implantation of the Mitral Touch Device

Rate of Technical Feasibility to implant the Mitral Touch Device

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: Device ImplantationExperimental Treatment1 Intervention

To epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy) using an epicardial implant.

0 / 18Eligibility criteria met