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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
92

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CorMatrix Cardiovascular, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Yale University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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