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CorMatrix Cor TRICUSPID ECM Valve Replacement Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 6, 2015
First Posted Date  ICMJE March 25, 2015
Last Update Posted Date January 14, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
Procedural Success [ Time Frame: 30 days postop ]
Device Success and No TV device- or TV procedure-related SAE's
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
Procedural Success as measured by: Device success and No TV device- or TV procedure-related SAE's [ Time Frame: 30 day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2015)
  • Device success as measured by: 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 [ Time Frame: 30 day and all follow up ]
  • Technical Success as measured by: Alive, with 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 [ Time Frame: within 24 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Official Title  ICMJE CorMatrix Cor TRICUSPID ECM Valve Replacement Safety and Early Feasibility
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Tricuspid Valve Disease
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Device: CorMatrix Cor TRICUSPID ECM Valve
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2015)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robert G Matheny, MD 404-276-7777 rmatheny@cormatrix.com
Contact: Edgar B Rey 404-285-0466 erey@cormatrix.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02397668
Other Study ID Numbers  ICMJE 14-PR-1101 Rev. G
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CorMatrix Cardiovascular, Inc.
Study Sponsor  ICMJE CorMatrix Cardiovascular, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Robert G Matheny, MD CorMatrix Cardiovascular, Inc.
PRS Account CorMatrix Cardiovascular, Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP