CorMatrix Cor TRICUSPID ECM Valve Replacement Study

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

Tracking Information

• First Submitted Date: March 6, 2015
• First Posted Date: March 25, 2015
• Last Update Posted Date: January 14, 2019
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 ]

Current Secondary Outcome Measures (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 (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: CorMatrix Cor TRICUSPID ECM Valve Replacement Study
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Tricuspid Valve Disease

Intervention

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

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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 19, 2015): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Year to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Robert G Matheny, MD; 404-276-7777; rmatheny@cormatrix.com

Contact: Edgar B Rey; 404-285-0466; erey@cormatrix.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02397668
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: CorMatrix Cardiovascular, Inc.
• Study Sponsor: CorMatrix Cardiovascular, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Robert G Matheny, MD; CorMatrix Cardiovascular, Inc.

• PRS Account: CorMatrix Cardiovascular, Inc.
• Verification Date: January 2019