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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Columbia University Irving Medical Center/New York PresbyterianNew York, NY
St Francis HospitalIndianapolis, IN
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Who is running the clinical trial?
CorMatrix Cardiovascular, Inc.Lead Sponsor
Yale UniversityCollaborator