CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal S... | NCT05742906

NCT05742906

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Yale University	OTHER

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Technical Success	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 \	One week or prior to hospital discharge

Eligibility Module

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

Name	Role	Phone	Extension	Email
Robert G Matheny, MD	Contact	404-276-7777		Rmatheny@Cormatrix.com
Brad Solberg, MBA	Contact	4084644001		brad@experiengroup.com

Name	Affiliation	Role
Robert Matheny, MD	Corvivo Cardiovascular, Inc.	Study Director
Brad Solberg, MBA	Veranex	Study Director

ID	Term
D006349	Heart Valve Diseases
D006331	Heart Diseases
D002318	Cardiovascular Diseases