ECM Valve Replacement for Tricuspid Valve Disease

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: CorMatrix Cardiovascular, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

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

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

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

I cannot take blood thinners like aspirin or Plavix.

I have had an emergency heart procedure.

My kidney function is significantly impaired.

Participant Groups

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.

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.