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ECM Valve Replacement

ECM Valve Replacement for Tricuspid Valve Disease

N/A

Recruiting

Research Sponsored by CorMatrix Cardiovascular, Inc.

Eligibility Criteria Checklist

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

Must have

Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures

Must not have

Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock

Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days postop

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new kind of valve to treat tricuspid valve disease in children. The goal is to show that it is safe and to identify any necessary changes to the implant procedure or device.

Who is the study for?

This trial is for patients needing tricuspid valve replacement due to disease, including children with congenital issues. Participants must understand the procedure, agree to follow-ups, and not be involved in other conflicting studies. Exclusions include severe heart failure, high lung pressures, recent major heart attack or stroke, significant kidney or liver dysfunction, cancer treatment within a year (except certain skin/cervical cancers), pregnancy, emergency surgery needs, blood disorders uncorrectable by transfusion.

What is being tested?

The study tests the safety and effectiveness of the CorMatrix Cor TRICUSPID ECM Valve as a surgical replacement for damaged tricuspid valves. It follows an Early Feasibility Study (EFS) and includes patients who may also undergo additional cardiac procedures during implantation.

What are the potential side effects?

While specific side effects are not listed here, potential risks could include reactions related to porcine material sensitivity since the valve is made from this source. Other general risks might involve complications from surgery such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.

Exclusion Criteria

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

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I had a severe heart attack leading to shock within the last week.

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I do not have a major illness with a life expectancy of less than one year.

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I have a blood disorder or am taking medication that affects my bone marrow.

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I cannot take blood thinners like aspirin or Plavix.

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I have had an emergency heart procedure.

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My kidney function is significantly impaired.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days postop

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

Treatment Details

Study Objectives

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

Primary study objectives

Procedural Success

Secondary study objectives

Device Success

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: CorMatrix Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention

Tricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects.

0 / 7Eligibility criteria met