Replacement of dysfunctional tricuspid valves using a new ECM valve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pivotal study aims to evaluate the safety and effectiveness of the Cor TRICUSPID ECM Valve for replacing dysfunctional tricuspid valves in both adult and pediatric patients. Participants will undergo a preoperative evaluation followed by the surgical implantation of the valve, with subsequent postoperative assessments at various intervals up to five years. The study seeks to determine whether the device can be safely implanted and effectively treat tricuspid valve disease and dysfunction. The data collected will support a Humanitarian Device Exemption application for the valve.

Why it matters

Who can join: the full rules

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

Where it's running

• St Francis Hospital
  Indianapolis, Indiana, United States Recruiting
• Columbia University Irving Medical Center/New York Presbyterian
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Robert G Matheny, MD
• Email: Rmatheny@Cormatrix.com
• Phone: 404-276-7777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• TruGamma tricuspid valve replacement for high-risk patients

  This trial tests the TruGamma tricuspid valve replacement system in high-risk patients with severe tricuspid regurgitation to see if it is safe and helps symptoms when added to standard medical care.

  Recruiting Jiangsu Trulive Medical Co., Ltd · Beijing, Beijing Municipality · NCT07691307

• Transcatheter Tricuspid Valve Replacement for Severe Tricuspid Regurgitation

  This trial tests the Laplace TTVR System to see if it safely and effectively treats adults with severe tricuspid regurgitation.

  Recruiting at 2 sites Laplace Interventional, Inc · Tulsa, Oklahoma and 1 other locations · NCT07687485

• Vyne TriNova Transcatheter Tricuspid Valve Replacement study for severe tricuspid regurgitation

  This trial tests the VDyne TriNova system in adults with symptomatic severe tricuspid regurgitation to see if it is safe and helps heart symptoms compared with an alternative device.

  Recruiting at 12 sites VDyne, Inc. · Phoenix, Arizona and 11 other locations · NCT07516444

• Investigating multiple and mixed heart valve diseases

  This study looks at how common different types of heart valve diseases are and their features by gathering information from patients around the world who have been diagnosed with these conditions.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris, Île-de-France Region · NCT06235385

• Evaluating the DUO System for treating Tricuspid Regurgitation

  This study is testing a new heart valve system to see if it can help people with severe tricuspid regurgitation feel better and improve their heart function.

  Recruiting at 17 sites CroiValve Limited · Phoenix, Arizona and 17 other locations · NCT05913908

• Transcatheter valve repair for severe tricuspid regurgitation

  This study is testing a new valve repair system to see if it helps people with severe tricuspid regurgitation feel better compared to just taking their medications.

  Recruiting at 45 sites Edwards Lifesciences · Phoenix, Arizona and 78 other locations · NCT04097145

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.