CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Study Overview
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Brief Summary
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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

Detailed Description
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CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the Cor TRICUSPID ECM Valve for adults and the Cor PEDIATRIC Tricuspid ECM Valve for pediatrics (collectively these devices will be referred to as the Cor TRICUSPID ECM Valve(s)), which can be implanted to replace dysfunctional tricuspid heart valves. The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM valve to support a Humanitarian Device Exemption (HDE) marketing application. Because the majority of tricuspid valve replacements (TVRs) (approximately 80%) are performed concomitantly with other cardiac operations, including replacements of mitral or aortic valves, it is anticipated that a portion of study subjects will require concomitant replacement or repair of a dysfunctional mitral or aortic valve, based on the clinical judgment of the investigator. Therefore, safety with the Cor TRICUSPID ECM Valve will be established by Procedural, Technical and Device Success.

Official Title
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CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

Conditions
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Tricuspid Valve Disease, Tricuspid Valve Insufficiency

Intervention / Treatment
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* Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Data will be collected and reported in the following four (4) groups/cohorts: Group A: Adults (≥ 21 years of age) treated with SIS 1.0 study devices Group B: Pediatrics (< 21 years of age) treated with SIS 1.0 study devices Group C: Adults Group A: Adults (≥ 21 years of age) treated with SIS 2.0 study devices Group D: Pediatrics (< 21 years of age) treated with SIS 2.0 study devices
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve<br>Adults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve<br>* Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.<br>|
| Other: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve<br>Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve<br>* Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.<br>|
| Other: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve<br>Adults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve<br>* Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.<br>|
| Other: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve<br>Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve<br>* Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Outcome - Procedural Success | Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs) | 30 days | 
| Effectiveness Outcome - Individual Patient Success | Device success and no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve [TV], recurrence of tricuspid regurgitation [TR] > moderate, or right sided heart failure [HF]) unless endocarditis is secondary to recurrent drug abuse. Improvement vs. baseline in symptoms (improvement in New York Heart Association [NYHA] [adult subjects] and clinical improvement [pediatric subjects] Class >/= 1 grade) | 6 months | 
| Effectiveness Outcome - Individual Patient Success | Device success and no Cor TRICUSPID ECM Valve-related re-hospitalizations or re-interventions of the Cor TRICUSPID ECM Valve (clinically significant: new endocarditis of the tricuspid valve [TV], recurrence of tricuspid regurgitation [TR] > moderate, or right sided heart failure [HF]) unless endocarditis is secondary to recurrent drug abuse. Improvement vs. baseline in symptoms (improvement in New York Heart Association [NYHA] [adult subjects] and clinical improvement [pediatric subjects] Class >/= 1 grade) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid Valve Disease, Tricuspid Valve Dysfunction, Tricuspid Valve Regurgitation, Tricuspid Valve Replacement