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Transcatheter Mitral Valve Replacement

Transcatheter Mitral Valve Replacement for Mitral Valve Regurgitation

N/A

Recruiting

Research Sponsored by HighLife SAS

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV

Must not have

Active ulcer or gastro-intestinal bleeding in the past 3 months

Patients with a life expectancy of less than 12 months due to non-cardiac conditions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after procedure

Awards & highlights

No Placebo-Only Group

Summary

This triallooks at the safety and performance of a transcatheter mitral valve for high-risk patients with moderate-severe and severe mitral regurgitation.

Who is the study for?

This trial is for adults over 18 with moderate to severe mitral valve regurgitation who are at high risk for surgery. Candidates must have been on medical therapy for a month, be in NYHA Functional Class II-IV, and meet specific anatomical criteria. Exclusions include recent stroke/TIA, severe carotid stenosis, pregnancy, inability to follow up or take blood thinners, recent pacemaker implantation, active infections or ulcers.

What is being tested?

The study tests the HighLife Transcatheter Mitral Valve Replacement System's safety and performance in patients with significant heart valve leakage who can't undergo standard surgery. It involves placing a new valve via catheter without open-heart surgery.

What are the potential side effects?

While not explicitly listed here, potential side effects may include bleeding due to anticoagulation therapy required after the procedure; risks associated with catheter-based interventions such as vascular complications; infection risks; and possible device-related complications.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have some limitations on physical activity due to heart problems.

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

Exclusion Criteria

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

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I have not had an active ulcer or GI bleeding in the last 3 months.

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My doctor expects I have less than 12 months to live due to a non-heart related condition.

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I cannot tolerate blood thinners or medications that prevent blood clots.

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I am currently on antibiotics for an infection.

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I have severe narrowing in my neck arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days post procedure

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

Continued intended performance of the HighLife™ bioprosthesis

Freedom of major adverse events

Secondary study objectives

Technical success

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 ReplacementExperimental Treatment1 Intervention

HighLife TMVR System is a novel and innovative approach developed as an alternative treatment for severe MR when medical treatment is maximal and surgical interventions not possible or at high risk. The HighLife TMVR system is composed of a Transcatheter Mitral Valve (TMV), a sub-annular implant (SAI), and their delivery systems and loading tools.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcatheter Mitral Valve Replacement

2017

N/A

~100

0 / 8Eligibility criteria met