CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

August 26, 2025 updated by: CorMatrix Cardiovascular, Inc.

CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Recruiting
        • St Francis Hospital
        • Principal Investigator:
          • Marc Gerdisch, MD
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center/New York Presbyterian
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • 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
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
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Other: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve
Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve
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.
Other: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve
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
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Other: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve
Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Outcome - Procedural Success
Time Frame: 30 days
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
30 days
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)
6 months
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)
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical Success
Time Frame: One week or prior to hospital discharge
  • Alive at exit from OR with:
  • Successful implant of the single intended Cor TRICUSPID ECM Valve
  • No need for additional emergency surgery or re-intervention related to the Cor TRICUSPID ECM Valve device
  • Final post-op transthoracic echocardiogram (TTE) (at 1 week or prior to discharge) shows tricuspid valve regurgitation </= moderate
One week or prior to hospital discharge
Device Success
Time Frame: 30 days

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
30 days
Device Success
Time Frame: 6 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
6 months
Device Success
Time Frame: 12 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
12 months
Device Success
Time Frame: 24 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
24 months
Device Success
Time Frame: 36 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
36 months
Device Success
Time Frame: 48 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
48 months
Device Success
Time Frame: 60 months

No device-related mortality, with

  • Original intended Cor TRICUSPID ECM Valve in place, and
  • No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and

  • Intended performance of the Cor TRICUSPID ECM Valve:

    1. No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse)

      • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and

    2. Expected hemodynamic performance:

      • Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and
      • Valve regurgitation ≤ moderate
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CorMatrix Cardiovascular, Inc.

Collaborators

Yale University

Investigators

  • Study Director: Robert Matheny, MD, CorMatrix Cardiovascular, Inc.
  • Study Director: Brad Solberg, MBA, Veranex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 30, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 26, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-PR-1101 Rev. L Pivotal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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