Actively Recruiting
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Led by Corvivo Cardiovascular, Inc. · Updated on 2025-09-02
78
Participants Needed
4
Research Sites
228 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a regurgitant or absent tricuspid valve requiring surgical treatment, including those with concomitant cardiac procedures
- Male or female patients
- Patient or legal guardian understands the procedure, agrees to follow-up evaluations, and provides written informed consent; pediatric patients provide assent if able
- Patient or legal guardian is geographically stable or willing to return for required follow-up and agrees to meet all study requirements
- Children with congenital heart disease where the Cor PEDIATRIC Tricuspid ECM Valve would serve as the physiological right-sided valve
You will not qualify if you...
- Tricuspid annulus smaller than 10 mm preventing valve placement
- Left ventricular ejection fraction less than 25%
- Mean pulmonary pressure over 50 mm Hg or pulmonary vascular resistance above 6 Woods Units
- Emergency cardiac procedures such as resuscitation or urgent unplanned surgery
- Cardiac transplant recipients
- Acute transmural myocardial infarction within 7 days causing cardiogenic shock
- Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve
- Primary coagulopathy or platelet disorders not correctable by transfusion
- Significant liver disease with enzyme levels five times above normal within 30 days, unless reversible
- Significant kidney dysfunction (serum creatinine above 4.0 mg/dl or GFR below 30)
- Stroke within 30 days before enrollment
- Major progressive non-cardiac diseases with less than one-year life expectancy
- Known cancer under treatment or cancer-free less than one year (excluding some skin and cervical cancers)
- Hematological disorders or use of bone marrow suppressant drugs
- Known allergy to porcine materials
- Contraindications to aspirin or Plavix therapy
- Pregnancy
- Enrollment in another investigational study impacting treatment or outcomes without CorMatrix approval
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Springhill Memorial Hospital
Mobile, Alabama, United States, 36607
Actively Recruiting
2
St Francis Hospital
Indianapolis, Indiana, United States, 46237
Actively Recruiting
3
Medstar
Baltimore, Maryland, United States, 21244
Actively Recruiting
4
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
R
Robert G Matheny, MD
CONTACT
R
Rhonda B Van Genderen, RN, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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