ECM Valve Replacement for Tricuspid Valve Disease

Recruiting at 1 trial location

Overseen By Brad Solberg, MBA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: CorMatrix Cardiovascular, Inc.

Must not be taking: Bone marrow suppressants

Disqualifiers: Small tricuspid annulus, Low LVEF, High pulmonary pressure, Emergency cardiac procedure, Cardiac transplant, others

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

Compensation: Varies

Number of Visits: Unknown

92 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new valve, the Cor TRICUSPID ECM Valve, designed to assist individuals with tricuspid valve disease, which impacts blood flow through the heart. The primary goals are to determine if the valve can be safely implanted and if it effectively treats the condition for up to 12 months. Participants will undergo surgery to replace their faulty valve and will be monitored through various check-ups over several years. This trial suits individuals needing surgery to repair a malfunctioning tricuspid valve, especially those willing to attend regular follow-up visits. As an unphased trial, it offers patients the chance to contribute to groundbreaking research and potentially benefit from an innovative treatment option.

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. However, if you have a contraindication to anticoagulation or antiplatelet therapy, you may not be eligible to participate.

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

Research has shown that the Cor TRICUSPID ECM Valve, used to replace the tricuspid valve in the heart, has promising safety results. In earlier studies, this valve did not experience major issues like clotting or hardening, common concerns with heart valve replacements. This suggests the valve is well-tolerated by patients.

For the SIS 1.0 version of the valve, early studies focused on its safety showed it could be implanted without major problems. Similarly, tests on the SIS 2.0 version have confirmed its safety for initial use in patients, with no significant safety issues reported.

Overall, both versions of the Cor TRICUSPID ECM Valve have demonstrated safety for patients needing a new tricuspid valve. While ongoing studies continue to gather more data, the results so far are encouraging for those considering participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cor TRICUSPID ECM Valve because it uses an extracellular matrix (ECM) technology that could offer a more natural approach to valve replacement. Unlike traditional mechanical or bioprosthetic valves, which can require lifelong blood thinners or have limited durability, the ECM valve is designed to integrate with the body's own tissues, potentially reducing complications and improving longevity. This innovative approach may lead to better outcomes, particularly for pediatric patients who need durable solutions as they grow.

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

Research has shown that the Cor TRICUSPID ECM Valve could be a promising treatment for tricuspid valve disease. Earlier studies found that patients who received this valve experienced improved heart function and fewer valve-related issues. This trial will evaluate different versions of the Cor TRICUSPID ECM Valve. Group A will include adults treated with the SIS 1.0 version, while Group B will focus on pediatrics receiving the same version. Group C will assess adults treated with the SIS 2.0 version, and Group D will involve pediatrics receiving the SIS 2.0 version. This treatment uses a special material that helps the body accept the valve more naturally, potentially lowering the risk of rejection. Initial results suggest the valve is safe and effective for both adults and children needing a tricuspid valve replacement. ^{1 2 3 4 6}

Who Is on the Research Team?

Brad Solberg, MBA

Principal Investigator

Veranex

Robert Matheny, MD

Principal Investigator

CorMatrix Cardiovascular, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

I need surgery for a faulty or missing tricuspid valve, possibly with other heart procedures.

Exclusion Criteria

I have a blood disorder or am taking medication that affects my bone marrow.

I have been cancer-free for less than a year, or I am currently undergoing cancer treatment.

I had a severe heart attack within the last week that caused my heart to fail.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Evaluation

Participants undergo preoperative evaluation before the tricuspid valve replacement surgery

1 week

Surgical Treatment

Tricuspid valve replacement with the Cor TRICUSPID ECM Valve

1 week

In-hospital stay

Postoperative Evaluation

Postoperative evaluation including at hospital discharge, 30 days, 6 months, and 12 months

12 months

Multiple visits at specified intervals

Long-term Follow-up

Annual follow-up evaluations through 5 years to monitor safety and effectiveness

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Cor TRICUSPID ECM Valve

Trial Overview 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.

How Is the Trial Designed?

Group I: Group D: Pediatrics treated with SIS 2.0 Cor TRICUSPID ECM Valve Experimental Treatment 1 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 Valve Experimental Treatment 1 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 Valve Experimental Treatment 1 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 Valve Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

CorMatrix Cardiovascular, Inc.

Lead Sponsor

Trials

5

Recruited

230+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

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. 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 ...

4. medicine.yale.edu medicine.yale.edu/ycci/clinicaltrials/trial/cormatrix-tricuspid-ecm-valve/

CorMatrix Cor TRICUSPID ECM Valve Replacement Study To demonstrate the proof of principle and initial clinical safety of the Cor TRICUSPID ECM Valve (or Cor PEDIATRIC Tricuspid ECM Valve)

5. withpower.com withpower.com/trial/phase-tricuspid-valve-insufficiency-3-2023-8781a

ECM Valve Replacement for Tricuspid Valve Disease The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC ...

6. journals.sagepub.com journals.sagepub.com/doi/10.1177/21501351251360694?int.sj-abstract.similar-articles.7

Contrasting the Performance of a Surgeon-Fashioned ... Although the CorMatrix tricuspid valve did not show significant signs of thrombosis or calcification, it was also replaced with a mechanical valve. That ...