RecruitingNot ApplicableNCT05742906

CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

Sponsor

Corvivo Cardiovascular, Inc.

Enrollment

92 participants

Start Date

Aug 10, 2022

Study Type

INTERVENTIONAL

Conditions

Tricuspid Valve Insufficiency Tricuspid Valve Disease

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

Inclusion Criteria4

Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
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
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
Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve

Exclusion Criteria18

Tricuspid annulus too small (< 10mm) to accommodate the Cor TRICUSPID ECM Valve
Left ventricular ejection fraction (LVEF) < 25%
Mean pulmonary pressure ≥ 50mmHg or pulmonary vascular resistance greater than 6 Woods Units
Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
Cardiac transplant patient
Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
Patients with a single ventricle where the Cor TRICUSPID ECM Valve would be the systemic AV valve
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
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)
Documented evidence of significant renal dysfunction (serum creatinine > 4.0mg/dl or GFR< 30 on the modified Schwartz formula)
Stroke within 30 days prior to enrollment
Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
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
Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
Known sensitivity to porcine materials
Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)
Patients who are pregnant (method of assessment Investigator's discretion)
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