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CorMatrix Cor TRICUSPID ECM Valve Replacement Study

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ClinicalTrials.gov Identifier: NCT02397668
Recruitment Status : Recruiting
First Posted : March 25, 2015
Last Update Posted : January 14, 2019
Sponsor:
Information provided by (Responsible Party):
CorMatrix Cardiovascular, Inc.

Brief Summary:
To demonstrate the proof of principle and initial clinical safety of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve) and increase the efficiency of the device development process by identifying appropriate modifications to the implant procedure or the device.

Condition or disease Intervention/treatment Phase
Tricuspid Valve Disease Device: CorMatrix Cor TRICUSPID ECM Valve Not Applicable

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 Early Feasibility Study is proposed to obtain initial insights into 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, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up to 8 sites.

Up to 15 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 10 adult patients and up to 5 pediatric patients.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Multi-center, prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2024

Arm Intervention/treatment
Experimental: CorMatrix Cor TRICUSPID ECM Valve
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 10 adults subjects and up to 5 pediatric subjects.
Device: CorMatrix Cor TRICUSPID ECM Valve
CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.
Other Name: Cor PEDIATRIC Tricuspid ECM Valve




Primary Outcome Measures :
  1. Procedural Success [ Time Frame: 30 days postop ]
    Device Success and No TV device- or TV procedure-related SAE's


Secondary Outcome Measures :
  1. Device Success [ Time Frame: 30 day and all follow up time points ]
    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

  2. Technical Success [ Time Frame: within 24 hours ]
    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



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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
  2. Male or female
  3. 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
  4. 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
  5. Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided 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 > 50mm Hg 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02397668


Contacts
Contact: Robert G Matheny, MD 404-276-7777 rmatheny@cormatrix.com
Contact: Edgar B Rey 404-285-0466 erey@cormatrix.com

Locations
United States, Alabama
Springhill Memorial Hospital Not yet recruiting
Mobile, Alabama, United States, 36607
Principal Investigator: Terry C Stelly, MD         
United States, Indiana
St Francis Hospital Recruiting
Indianapolis, Indiana, United States, 46237
Principal Investigator: Marc Gerdisch, MD         
United States, Ohio
Cincinnati Children's Hospital Not yet recruiting
Cincinnati, Ohio, United States, 45229
Principal Investigator: David Morales, MD         
Sponsors and Collaborators
CorMatrix Cardiovascular, Inc.
Investigators
Study Director: Robert G Matheny, MD CorMatrix Cardiovascular, Inc.

Responsible Party: CorMatrix Cardiovascular, Inc.
ClinicalTrials.gov Identifier: NCT02397668     History of Changes
Other Study ID Numbers: 14-PR-1101 Rev. G
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes