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New treatment option for Tricuspid Valve Disease
Official title CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
ClinicalTrials.gov ID: NCT05742906
What this study is testing
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- 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...
- Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is...
- Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve
You likely can't join if
- 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...
- Cardiac transplant patient
- Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
See the full eligibility 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)...
- 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...
- Patients where the Cor TRICUSPID ECM Valve will be the physiological right-sided atrioventricular (AV) valve
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- New York, New York, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.