CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Eligible age
All ages
Accepts
All genders
Locations
2 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Corvivo Cardiovascular, Inc.
You may qualify if…
- ✓ 1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
- ✓ 2. Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
- ✓ 3. Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
- ✓ 4. Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve
You may not qualify if…
- ✕ 1. Tricuspid annulus too small (\< 10mm) to accommodate the Cor TRICUSPID ECM Valve
- ✕ 2. Left ventricular ejection fraction (LVEF) \< 25%
- ✕ 3. Mean pulmonary pressure ≥ 50mmHg or pulmonary vascular resistance greater than 6 Woods Units
- ✕ 4. Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
- ✕ 5. Cardiac transplant patient
- ✕ 6. Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
- ✕ 7. Patients with a single ventricle where the Cor TRICUSPID ECM Valve would be the systemic AV valve
- ✕ 8. Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count \< 30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets
Where it's recruiting
Source: ClinicalTrials.gov · NCT05742906 · last updated 2025-09-02