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ECM Valve Replacement

ECM Valve Replacement for Tricuspid Valve Disease

N/A
Recruiting
Research Sponsored by CorMatrix Cardiovascular, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
Must not have
Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the safety and effectiveness of a new tricuspid valve to treat valve disease in adults and children.

Who is the study for?
This trial is for adults and children with tricuspid valve disease needing surgery, who understand the procedure and can follow up. It's not for those with recent strokes, contraindications to blood thinners, severe liver or kidney issues, very low heart function, high lung pressures, certain heart configurations (like a single ventricle as systemic AV valve), active cancers or major non-cardiac diseases.
What is being tested?
The study tests the Cor TRICUSPID ECM Valve in patients requiring tricuspid valve replacement. Success and safety of implantation are evaluated along with effectiveness in treating valve dysfunction over 12 months. Follow-ups occur after surgery at set intervals up to five years.
What are the potential side effects?
Potential side effects may include reactions related to the body accepting the new valve material from porcine sources (if sensitive), complications from necessary blood thinners post-surgery, and general risks associated with cardiac surgeries such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a blood disorder or am taking medication that affects my bone marrow.
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I had a severe heart attack within the last week that caused my heart to fail.
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My liver tests are more than 5 times the normal limit.
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My kidney function is significantly impaired.
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I cannot take blood thinners like aspirin or Plavix.
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I have had an emergency heart procedure.
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I have a single ventricle heart condition needing a specific valve replacement.
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I do not have a major illness with a life expectancy of less than one year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effectiveness Outcome - Individual Patient Success
Safety Outcome - Procedural Success
Other study objectives
Device Success
Technical Success

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Pediatrics (\<21 years of age) treated with SIS 2.0 Cor TRICUSPID ECM Valve
Group II: Group C: Adults treated with SIS 2.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Adults (\>/= 21 years of age) treated with the SIS 2.0 Cor TRICUSPID ECM Valve
Group III: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Pediatrics (\<21 years of age) treated with SIS 1.0 Cor TRICUSPID ECM Valve
Group IV: Group A: Adults treated with SIS 1.0 Cor TRICUSPID ECM ValveExperimental Treatment1 Intervention
Adults (\>/= 21 years of age) treated with the SIS 1.0 Cor TRICUSPID ECM Valve

Find a Location

Who is running the clinical trial?

Yale UniversityOTHER
1,930 Previous Clinical Trials
3,033,366 Total Patients Enrolled
CorMatrix Cardiovascular, Inc.Lead Sponsor
4 Previous Clinical Trials
139 Total Patients Enrolled
Brad Solberg, MBAStudy DirectorVeranex
Robert G Matheny, MDStudy DirectorCorMatrix Cardiovascular, Inc.
1 Previous Clinical Trials
78 Total Patients Enrolled
Robert Matheny, MDStudy DirectorCorMatrix Cardiovascular, Inc.

Media Library

Cor TRICUSPID ECM Valve (ECM Valve Replacement) Clinical Trial Eligibility Overview. Trial Name: NCT05742906 — N/A
Tricuspid Regurgitation Research Study Groups: Group B: Pediatrics treated with SIS 1.0 Cor TRICUSPID ECM Valve, Group A: Adults 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
Tricuspid Regurgitation Clinical Trial 2023: Cor TRICUSPID ECM Valve Highlights & Side Effects. Trial Name: NCT05742906 — N/A
Cor TRICUSPID ECM Valve (ECM Valve Replacement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05742906 — N/A
~28 spots leftby Dec 2025
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