Tricuspid Valve DiseaseNCT02397668
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
A study testing CorMatrix Cor TRICUSPID ECM Valve in people with Tricuspid Valve Disease, run by Corvivo Cardiovascular, Inc. at 4 sites in United States.
Trial summary
The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve. Read more about this study
- Who is it for?
- Ages 1 year to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Tricuspid Valve Disease
- What is being tested?
- CorMatrix Cor TRICUSPID ECM Valve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Aug 2022to 15 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 1 year to 85 years
- All sexes
- Healthy volunteers accepted
- 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
- Male or female
- 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
- Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided 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 > 50mm Hg 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
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Medstar
Baltimore, Maryland, 21244
Brian Bethea, MD
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
David Morales, MD
- Recruiting
St Francis Hospital
Indianapolis, Indiana, 46237
Marc Gerdisch, MD
- Recruiting
Springhill Memorial Hospital
Mobile, Alabama, 36607
William C Johnson, MD
About this study
The Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.
Read the detailed description
CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Pivotal Study is being performed to verify the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Pivotal Study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 15 sites.
Up to 60 subjects will undergo tricuspid valve replacement (TVR) with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease. The cohort will include up to 60 adult and 18 pediatric patients.
- Conditions
- Tricuspid Valve Disease
- Being tested
- CorMatrix Cor TRICUSPID ECM Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorMatrix Cor TRICUSPID ECM ValveDevice
Also called Cor PEDIATRIC Tricuspid ECM Valve
CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.
| Study group | Role | What they receive |
|---|---|---|
| CorMatrix Cor TRICUSPID ECM Valve | Experimental | Tricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects. Receives: Device: CorMatrix Cor TRICUSPID ECM Valve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Device Success and No TV device- or TV procedure-related SAE's
Measured: 30 days postop
Secondary outcomes (2)
Device Success
Patient alive with original intended CorMatrix ECM TV in place, No additional surgical or interventional procedures related to the TV, and Intended performance of the TV
Measured: 30 day and all follow up time points
Technical Success
Exit OR Alive, Successful implant of the single intended CorMatrix ECM TV, No need for additional emergency surgery or re-intervention related to the TV device, Final post-op TTE shows TR < moderate
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start1 Aug 2022
- Primary completion15 Dec 2025 (estimated)
- Study completion15 Dec 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
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-center, prospective, single-arm, Pivotal study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corvivo Cardiovascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert G Matheny, MD, Study director, Corvivo Cardiovascular, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397668
- Sponsor's protocol ID
- 14-PR-1101 Rev. L
- Status last verified
- Aug 2025
- First submitted
- 6 Mar 2015
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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
- NCT02397668
- Acronym / sponsor ID
- 14-PR-1101 Rev. L
- Conditions
- Tricuspid Valve Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Corvivo Cardiovascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 15 Dec 2025 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 25 Mar 2015 (estimated)
- 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 Pivotal Study of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve). This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement of the tricuspid valve.
Detailed description
CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional tricuspid heart valves. This Pivotal Study is being performed to verify the ability to successfully implant the Tricuspid Valve, the clinical safety of the device, and whether the device performs its intended use. The study is a multi-center, prospective, single-arm, Pivotal Study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 15 sites.
Up to 60 subjects will undergo tricuspid valve replacement (TVR) with the CorMatrix ECM Valve for the surgical management of tricuspid valve disease. The cohort will include up to 60 adult and 18 pediatric patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-center, prospective, single-arm, Pivotal study of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve
| Arm | Type | Receives |
|---|---|---|
| CorMatrix Cor TRICUSPID ECM Valve | Experimental | Device: CorMatrix Cor TRICUSPID ECM ValveTricuspid valve replacement in patients for the surgical management of tricuspid valve disease, including tricuspid valve disease secondary to congenital heart disease. Enrollment will include up to 60 adults subjects and up to 18 pediatric subjects. |
Who may qualify
- Ages
- 1 year to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
- Male or female
- 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
- Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided 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 > 50mm Hg 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 |
|---|---|---|
| CorMatrix Cor TRICUSPID ECM ValveAlso: Cor PEDIATRIC Tricuspid ECM ValveCorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease. | Device | CorMatrix Cor TRICUSPID ECM Valve |
Primary outcome
Procedural Success
Time frame: 30 days postop
Device Success and No TV device- or TV procedure-related SAE's
2 secondary outcomes
Device Success
Time frame: 30 day and all follow up time points
Technical Success
Time frame: within 24 hours
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
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The TRICURE US IDE Pivotal Study
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TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE 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 G Matheny, MD study director
Corvivo Cardiovascular, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorMatrix Cor TRICUSPID ECM Valve in people with Tricuspid Valve Disease, run by Corvivo Cardiovascular, Inc. at 4 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 5 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 4 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?
Procedural Success (time frame: 30 days postop). 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.