Actively Recruiting
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Led by Corvivo Cardiovascular, Inc. · Updated on 2025-09-02
78
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the CorMatrix Cor TRICUSPID ECM Valve, a device designed to replace dysfunctional tricuspid heart valves, in patients needing surgical valve replacement. This pivotal study aims to confirm the device's safe implantation, clinical safety, and performance in treating tricuspid valve disease, including cases secondary to congenital heart disease. The study includes both adult and pediatric patients and is conducted at multiple centers. Participants will undergo tricuspid valve replacement surgery using the CorMatrix ECM Valve. The study includes up to 60 adult and 18 pediatric patients receiving this device. The trial is a single-arm, prospective study focusing on the surgical management of tricuspid valve disease with this valve replacement device. During the study, participants will be followed to assess procedural success at 30 days post-operation, device success at 30 days and subsequent visits, and technical success within 24 hours after implantation. Researchers will monitor safety and performance through clinical evaluations and follow-up visits. The total participation duration extends through the follow-up period to evaluate outcomes after the valve replacement.
CONDITIONS
Brief Title
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
- Male or female
- Patient or authorized legal guardian understands the procedure and is willing to comply with follow-up evaluations and provides written informed consent; pediatric patients provide assent if able
- Patient or legal guardian is geographically stable or willing to return for required follow-up and agrees to meet all study requirements
- Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve
You will not qualify if you...
- Tricuspid annulus too small (< 10mm) to accommodate the Cor Tricuspid ECM Valve
- Left ventricular ejection fraction (LVEF) less than 25%
- Mean pulmonary pressure greater than 50mm Hg or pulmonary vascular resistance over 6 Woods Units
- Emergency cardiac procedure such as resuscitation or unplanned surgery
- Cardiac transplant patient
- Acute transmural myocardial infarction within 7 days causing 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 unless reversible by transfusions
- Significant liver disease with enzyme levels over 5 times normal within 30 days unless reversible
- Significant kidney dysfunction with serum creatinine over 4.0mg/dl or GFR below 30
- Stroke within 30 days prior to enrollment
- Major or progressive non-cardiac diseases with life expectancy under one year
- Known cancer within last year or ongoing treatment except certain skin or cervical cancers
- Hematological disorders or patients on bone marrow suppressant drugs
- Known sensitivity to porcine materials
- Contraindication to anticoagulation or antiplatelet therapy
- Pregnant patients
- Currently enrolled in another investigational study or registry affecting this study without approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospital stay duration until discharge
Participants undergo tricuspid valve replacement surgery using the CorMatrix Cor TRICUSPID ECM Valve and receive immediate post-operative care.
1 surgical visit (in-person) plus immediate post-operative care visits
Duration - Up to 30 days post surgery
Participants are monitored for procedural success, device safety, and valve performance after surgery.
Multiple visits up to 30 days post-operative
Trial Site Locations
Total: 4 locations
1
Springhill Memorial Hospital
Mobile, Alabama, United States, 36607
Actively Recruiting
2
St Francis Hospital
Indianapolis, Indiana, United States, 46237
Actively Recruiting
3
Medstar
Baltimore, Maryland, United States, 21244
Actively Recruiting
4
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
Research Team
R
Robert G Matheny, MD
R
Rhonda B Van Genderen, RN, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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