ECM Valve Replacement for Tricuspid Valve Disease

Recruiting at 3 trial locations

Overseen By Rhonda B Van Genderen, RN, MBA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: CorMatrix Cardiovascular, Inc.

Must not be taking: Bone marrow suppressants

Disqualifiers: Cardiac transplant, Stroke, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new heart valve, the CorMatrix Cor TRICUSPID ECM Valve, for individuals needing tricuspid valve replacement surgery. The researchers aim to determine if this valve is safe and effective for patients with tricuspid valve disease, which can sometimes stem from congenital issues. Suitable candidates for this trial include those requiring a new tricuspid valve and undergoing surgery, including children with congenital heart problems. As an unphased trial, it offers patients the chance to contribute to innovative heart valve research and potentially benefit from cutting-edge medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the CorMatrix Cor TRICUSPID ECM Valve is safe for tricuspid valve replacement?

Research has shown that the CorMatrix Cor TRICUSPID ECM Valve underwent safety testing in earlier studies. These studies assessed patient tolerance during tricuspid valve replacement surgery. Results indicated that the valve can be implanted safely.

Patients in these studies did not report any unexpected harmful effects, suggesting the valve is generally well-tolerated. Since this trial is not in an early phase, some safety data is already available. However, participating in any trial carries some risk because the treatment remains under study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CorMatrix Cor TRICUSPID ECM Valve is unique because it uses a special extracellular matrix (ECM) material to replace the tricuspid valve. Unlike traditional mechanical or bioprosthetic valves, which can require patients to take lifelong blood thinners or have limited durability, the ECM valve is designed to integrate with the patient's own tissue, potentially leading to better long-term outcomes. Researchers are excited about this treatment because it could reduce complications associated with traditional valve replacements and improve the quality of life for both adult and pediatric patients with tricuspid valve disease.

What evidence suggests that the CorMatrix Cor TRICUSPID ECM Valve is effective for tricuspid valve disease?

Research has shown that the CorMatrix Cor TRICUSPID ECM Valve, which participants in this trial will receive, could be a promising treatment for tricuspid valve disease. Studies have found that surgeons can safely use this valve to replace the tricuspid valve. Made from a special material that mimics natural tissue, it may function effectively in the body. Early results suggest that patients who received this valve experienced positive outcomes, with the valve functioning properly without major issues. This indicates it could be a good option for those needing tricuspid valve surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Robert G Matheny, MD

Principal Investigator

CorMatrix Cardiovascular, Inc.

Are You a Good Fit for This Trial?

This trial is for patients needing tricuspid valve replacement due to disease, including children with congenital issues. Participants must understand the procedure, agree to follow-ups, and not be involved in other conflicting studies. Exclusions include severe heart failure, high lung pressures, recent major heart attack or stroke, significant kidney or liver dysfunction, cancer treatment within a year (except certain skin/cervical cancers), pregnancy, emergency surgery needs, blood disorders uncorrectable by transfusion.

Inclusion Criteria

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

I am either male or female.

Exclusion Criteria

Patients who are pregnant (method of assessment Investigator's discretion)

Known sensitivity to porcine materials

My liver tests are more than 5 times the normal limit, not due to a temporary issue.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Procedure

Participants undergo tricuspid valve replacement with the CorMatrix ECM Valve

1 day

1 visit (in-person)

Immediate Postoperative Monitoring

Participants are monitored for technical success and immediate postoperative outcomes

24 hours

Follow-up

Participants are monitored for safety and effectiveness after the procedure

30 days

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CorMatrix Cor TRICUSPID ECM Valve

Trial Overview The study tests the safety and effectiveness of the CorMatrix Cor TRICUSPID ECM Valve as a surgical replacement for damaged tricuspid valves. It follows an Early Feasibility Study (EFS) and includes patients who may also undergo additional cardiac procedures during implantation.

How Is the Trial Designed?

Group I: CorMatrix Cor TRICUSPID ECM Valve Experimental Treatment 1 Intervention

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 60 adults subjects and up to 18 pediatric subjects.

Who Is Running the Clinical Trial?

CorMatrix Cardiovascular, Inc.

Lead Sponsor

Trials

5

Recruited

230+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05742906

CorMatrix Cor TRICUSPID ECM Valve Replacement The objective of this Pivotal Study is to collect safety and effectiveness data on surgical tricuspid valve replacement procedures using the Cor TRICUSPID ECM ...

2. yalemedicine.org yalemedicine.org/clinical-trials/cormatrix-tricuspid-ecm-valve

CorMatrix Cor TRICUSPID ECM Valve Replacement Study The study is a multi-center, prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor TRICUSPID ECM Valve or Cor ...

3. mayo.edu mayo.edu/research/clinical-trials/cls-20148450

CorMatrix ECM Tricuspid Valve Replacement About this study. To demonstrate the proof of principle and initial clinical safety of the CorMatrix ECM Tricuspid Valve and increase the efficiency of the ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02397668?tab=table

CorMatrix Cor TRICUSPID ECM Valve Replacement Study This study follows the EFS and is now to determine the safety and efficacy of the Cormatrix Cor TRICUSPID Valve for any patients requiring surgical replacement ...

5. medicine.yale.edu medicine.yale.edu/trial/cormatrix-tricuspid-ecm-valve/

CorMatrix Cor TRICUSPID ECM Valve Replacement Study What is the purpose of this trial? To demonstrate the proof of principle and initial clinical safety of the Cor TRICUSPID ECM Valve (or Cor ...