Tricuspid Valve DiseaseNCT05742906
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
A study testing Tricuspid valve replacement with the Cor TRICUSPID ECM Valve in people with Tricuspid Valve Disease and Tricuspid Valve Insufficiency, run by Corvivo Cardiovascular, Inc. at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tricuspid Valve Disease, Tricuspid Valve Insufficiency
- What is being tested?
- Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Aug 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
St Francis Hospital
Indianapolis, Indiana, 46237
Marc Gerdisch, MD, (317) 851-2331, mgerdisch@openheart.net
Marc Gerdisch, MD
- Recruiting
Columbia University Irving Medical Center/New York Presbyterian
New York, New York, 10032
Emile Bacha, MD, 1-212-305-2688, eb2709@cumc.columbia.edu
About this study
Official title: 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
Read more
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
Read the 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.
- Being tested
- Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
- Keywords
- Tricuspid Valve Disease, Tricuspid Valve Dysfunction, Tricuspid Valve Regurgitation, Tricuspid Valve Replacement
- Medical subject headings
- Tricuspid Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricuspid valve replacement with the Cor TRICUSPID ECM ValveDevice
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve | Other | Adults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve Receives: Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve |
| Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve | Other | Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve Receives: Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve |
| Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve | Other | Adults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve Receives: Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve |
| Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve | Other | Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve Receives: Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome - Procedural Success
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
Measured: 30 days
Effectiveness Outcome - Individual Patient Success
- 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)
Measured: 6 months
Effectiveness Outcome - Individual Patient Success
- 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)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start10 Aug 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tricuspid Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Data will be collected and reported in the following four (4) groups/cohorts: * Group A: Adults (≥ 21 years of age) treated with SIS 1.0 study devices * Group B: Pediatrics (\< 21 years of age) treated with SIS 1.0 study devices * Group C: Adults Group A: Adults (≥ 21 years of age) treated with SIS 2.0 study devices * Group D: Pediatrics (\< 21 years of age) treated with SIS 2.0 study devices
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corvivo Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Responsible party
- Sponsor
- Investigators
- Robert Matheny, MD, Study director, Corvivo Cardiovascular, Inc.Brad Solberg, MBA, Study director, Veranex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742906
- Sponsor's protocol ID
- 14-PR-1101 Rev. L Pivotal
- Status last verified
- May 2025
- First submitted
- 30 Jan 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study
- ClinicalTrials.gov ID
- NCT05742906
- Acronym / sponsor ID
- 14-PR-1101 Rev. L Pivotal
- Keywords
- Tricuspid Valve Disease, Tricuspid Valve Dysfunction, Tricuspid Valve Regurgitation, Tricuspid Valve Replacement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Corvivo Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Yale University
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Data will be collected and reported in the following four (4) groups/cohorts: * Group A: Adults (≥ 21 years of age) treated with SIS 1.0 study devices * Group B: Pediatrics (< 21 years of age) treated with SIS 1.0 study devices * Group C: Adults Group A: Adults (≥ 21 years of age) treated with SIS 2.0 study devices * Group D: Pediatrics (< 21 years of age) treated with SIS 2.0 study devices
| Arm | Type | Receives |
|---|---|---|
| Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve | Other | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM ValveAdults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve |
| Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve | Other | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM ValvePediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve |
| Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve | Other | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM ValveAdults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve |
| Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve | Other | Device: Tricuspid valve replacement with the Cor TRICUSPID ECM ValvePediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tricuspid valve replacement with the Cor TRICUSPID ECM ValveTricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction. | Device | Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve, Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve, Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve, Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No. No.
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First-in-man Trial to Assess the Safety, Performance and Clinical Benefit of the TRICENTO G2 Transcatheter Valve System for Tricuspid Regurgitation
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The TRICURE US IDE Pivotal Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Matheny, MD study director
Corvivo Cardiovascular, Inc.
Brad Solberg, MBA study director
Veranex
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricuspid valve replacement with the Cor TRICUSPID ECM Valve in people with Tricuspid Valve Disease and Tricuspid Valve Insufficiency, run by Corvivo Cardiovascular, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Robert G Matheny, MD (404-276-7777, Rmatheny@Cormatrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcome - Procedural Success (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.