NCT05742906 CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
| NCT ID | NCT05742906 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corvivo Cardiovascular, Inc. |
| Condition | Tricuspid Valve Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2022-08-10 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2022-08-10 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 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 Exclusion Criteria: 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 9. Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are \> 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator) 10. Documented evidence of significant renal dysfunction (serum creatinine \> 4.0mg/dl or GFR\< 30 on the modified Schwartz formula) 11. Stroke within 30 days prior to enrollment 12. Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year 13. Known cancer (cancer-free ≤ 1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy 14. Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs 15. Known sensitivity to porcine materials 16. Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix) 17. Patients who are pregnant (method of assessment Investigator's discretion) 18. Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval
Contact & Investigator
Robert Matheny, MD
STUDY DIRECTOR
Corvivo Cardiovascular, Inc.
Frequently Asked Questions
Who can join the NCT05742906 clinical trial?
This trial is open to participants of all sexes, studying Tricuspid Valve Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05742906 currently recruiting?
Yes, NCT05742906 is actively recruiting participants. Contact the research team at Rmatheny@Cormatrix.com for enrollment information.
Where is the NCT05742906 trial being conducted?
This trial is being conducted at Indianapolis, United States, New York, United States.
Who is sponsoring the NCT05742906 clinical trial?
NCT05742906 is sponsored by Corvivo Cardiovascular, Inc.. The principal investigator is Robert Matheny, MD at Corvivo Cardiovascular, Inc.. The trial plans to enroll 92 participants.