ECM Valve Replacement for Tricuspid Valve Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Age: Any Age

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: CorMatrix Cardiovascular, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and dysfunction in adult and pediatric patients. The main question(s) it aims to answer are: * whether the device may be implanted successfully and safely, and * whether the device effectively treats tricuspid valve disease and dysfunction through 12 months Participants will undergo: * preoperative evaluation * tricuspid valve replacement with the Cor TRICUSPID ECM Valve * postoperative evaluation, including at hospital discharge, 30 days, 6 months, and 12 months, and then annually thereafter through 5 years

Eligibility Criteria

This trial is for adults and children with tricuspid valve disease needing surgery, who understand the procedure and can follow up. It's not for those with recent strokes, contraindications to blood thinners, severe liver or kidney issues, very low heart function, high lung pressures, certain heart configurations (like a single ventricle as systemic AV valve), active cancers or major non-cardiac diseases.

Inclusion Criteria

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

Exclusion Criteria

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

I had a severe heart attack within the last week that caused my heart to fail.

My liver tests are more than 5 times the normal limit.

My kidney function is significantly impaired.

I cannot take blood thinners like aspirin or Plavix.

I have had an emergency heart procedure.

I have a single ventricle heart condition needing a specific valve replacement.

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

Participant Groups

The study tests the Cor TRICUSPID ECM Valve in patients requiring tricuspid valve replacement. Success and safety of implantation are evaluated along with effectiveness in treating valve dysfunction over 12 months. Follow-ups occur after surgery at set intervals up to five years.

4Treatment groups

Experimental Treatment

Group I: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention

Pediatrics (\<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve

Group II: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention

Adults (\>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve

Group III: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention

Pediatrics (\<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve

Group IV: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention

Adults (\>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve