CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

NCT05742906 | Recruiting DMC FDA Device

• 1 other identifier: 14-PR-1101 Rev. L Pivotal
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Tricuspid Valve Disease; Tricuspid Valve Insufficiency

Keywords

Tricuspid Valve Disease; Tricuspid Valve Dysfunction; Tricuspid Valve Regurgitation; Tricuspid Valve Replacement

Outcome Measures

Primary Outcomes (3)

• Safety Outcome - Procedural Success

  Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)

  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)

  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)

  12 months

Other Outcomes (8)

• Technical Success

  One week or prior to hospital discharge

• Device Success

  30 days

• Device Success

  6 months

Study Arms (4)

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

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

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

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

Device: Tricuspid valve replacement with the Cor TRICUSPID ECM Valve

Interventions

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve DEVICE

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Corvivo Cardiovascular, Inc.: lead
• Yale University: collaborator

Study Sites (2)

St Francis Hospital

Indianapolis, Indiana, 46237, United States

RECRUITING

Columbia University Irving Medical Center/New York Presbyterian

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Robert Matheny, MD

  Corvivo Cardiovascular, Inc.

  STUDY DIRECTOR

• Brad Solberg, MBA

  Veranex

  STUDY DIRECTOR

Central Study Contacts

Robert G Matheny, MD

CONTACT

404-276-7777; Rmatheny@Cormatrix.com

Brad Solberg, MBA

CONTACT

4084644001; brad@experiengroup.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 24, 2023
• Study Start: August 10, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)