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CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

Primary Purpose

Tricuspid Valve Disease, Tricuspid Valve Insufficiency

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
Sponsored by
CorMatrix Cardiovascular, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tricuspid Valve Disease focused on measuring Tricuspid Valve Disease, Tricuspid Valve Dysfunction, Tricuspid Valve Regurgitation, Tricuspid Valve Replacement

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • St Francis HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

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

Arm Description

Adults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve

Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve

Adults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve

Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 30, 2023
Last Updated
February 14, 2023
Sponsor
CorMatrix Cardiovascular, Inc.
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT05742906
Brief Title
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
Official Title
CorMatrix® Cor™ TRICUSPID ECM® Valve Replacement Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CorMatrix Cardiovascular, Inc.
Collaborators
Yale University

4. Oversight

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the Cor TRICUSPID ECM Valve for adults and the Cor PEDIATRIC Tricuspid ECM Valve for pediatrics (collectively these devices will be referred to as the Cor TRICUSPID ECM Valve(s)), which can be implanted to replace dysfunctional tricuspid heart valves. The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM valve to support a Humanitarian Device Exemption (HDE) marketing application. Because the majority of tricuspid valve replacements (TVRs) (approximately 80%) are performed concomitantly with other cardiac operations, including replacements of mitral or aortic valves, it is anticipated that a portion of study subjects will require concomitant replacement or repair of a dysfunctional mitral or aortic valve, based on the clinical judgment of the investigator. Therefore, safety with the Cor TRICUSPID ECM Valve will be established by Procedural, Technical and Device Success.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tricuspid Valve Disease, Tricuspid Valve Insufficiency
Keywords
Tricuspid Valve Disease, Tricuspid Valve Dysfunction, Tricuspid Valve Regurgitation, Tricuspid Valve Replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM Valve
Arm Type
Other
Arm Description
Adults (>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve
Arm Title
Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve
Arm Type
Other
Arm Description
Pediatrics (<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve
Arm Title
Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM Valve
Arm Type
Other
Arm Description
Adults (>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve
Arm Title
Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve
Arm Type
Other
Arm Description
Pediatrics (<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve
Intervention Type
Device
Intervention Name(s)
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
Intervention Description
Tricuspid valve replacement with the Cor TRICUSPID ECM Valve for the surgical management of tricuspid valve disease or dysfunction.
Primary Outcome Measure Information:
Title
Safety Outcome - Procedural Success
Description
Device Success and no tricuspid valve device-related Serious Adverse Events (SAEs)
Time Frame
30 days
Title
Effectiveness Outcome - Individual Patient Success
Description
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)
Time Frame
6 months
Title
Effectiveness Outcome - Individual Patient Success
Description
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)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Technical Success
Description
Alive at exit from OR with: Successful implant of the single intended Cor TRICUSPID ECM Valve No need for additional emergency surgery or re-intervention related to the Cor TRICUSPID ECM Valve device Final post-op transthoracic echocardiogram (TTE) (at 1 week or prior to discharge) shows tricuspid valve regurgitation </= moderate
Time Frame
One week or prior to hospital discharge
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
30 days
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
6 months
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
12 months
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
24 months
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
36 months
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
48 months
Title
Device Success
Description
No device-related mortality, with Original intended Cor TRICUSPID ECM Valve in place, and No additional surgical or interventional procedures related to the Cor TRICUSPID ECM Valve, and Intended performance of the Cor TRICUSPID ECM Valve: No clinically significant dysfunction of the tricuspid valve: defined as TR > moderate (except patients with recurrent drug abuse) • This includes clinically significant: detachment of the annular or papillary muscle fixation, hemolysis, para-device complications (effects on coronary circulation, paravalvular leaks) or new endocarditis, and Expected hemodynamic performance: Valve mean gradient < 6mmHg [with heart rate ≤70 bpm for age ≥ 14; no HR restrictions for those <14 years] and Valve regurgitation ≤ moderate
Time Frame
60 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert G Matheny, MD
Phone
404-276-7777
Email
Rmatheny@cormatrix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rhonda Van Genderen, RN, MBA
Phone
715-441-5411
Email
Rvangenderen@cormatrix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert G Matheny, MD
Organizational Affiliation
CorMatrix Cardiovascular, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
St Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Gerdisch, MD
Phone
317-851-2331
Email
mgerdisch@openheart.net
First Name & Middle Initial & Last Name & Degree
Marc Gerdisch, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No.

Learn more about this trial

CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study

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