NCT05742906 · Corvivo Cardiovascular, Inc.
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Primary outcome measures
Safety Outcome - Procedural Success
Time frame: 30 days
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
Effectiveness Outcome - Individual Patient Success
Time frame: 6 months
* 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)
Effectiveness Outcome - Individual Patient Success
Time frame: 12 months
* 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)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Indianapolis, Indiana
- New York, New York
Collaborators
Yale University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 2, 2025 · Source of record for eligibility and locations