MITRIS RESILIA Mitral Valve for Mitral Valve Disease

(MOMENTIS Trial)

Not currently recruiting at 36 trial locations

Overseen By Sabrina Hundt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Disqualifiers: Endocarditis, Stage 4 renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 0 to 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather real-world data on the safety and performance of the MITRIS RESILIA Mitral Valve, a device used to replace a faulty mitral valve in the heart. It focuses on individuals requiring surgery to replace their native (original) or prosthetic (artificial) mitral valve. Suitable candidates for this trial are those whose mitral valve is not functioning properly and who need replacement surgery. Participants will help researchers assess the valve's effectiveness both immediately after surgery and over the long term. As a Phase 4 trial, this study involves an FDA-approved treatment, allowing participants to contribute to understanding its benefits for more patients.

Do I need to stop my current medications for the trial?

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

What prior data suggests that the MITRIS RESILIA Mitral Valve, Model 11400M, is safe for mitral valve replacement?

Research has shown that the MITRIS RESILIA Mitral Valve has been used in patients for some time, with reports on its safety and effectiveness. Some information indicates that a valve was removed after four months, suggesting possible complications, though this occurrence is not common. Like any heart valve, risks exist, but specific details on negative effects are not widely available.

The valve is intended for individuals needing a new mitral valve, a crucial part of the heart. The research aims to assess the valve's safety and effectiveness over time. As it is studied in real-life situations, noting any problems or benefits experienced by patients is important.

If the MITRIS valve resembles other approved valves, it might be well-tolerated. However, without more comprehensive data, determining its exact safety is challenging. Consulting a doctor is essential to determine if this option is suitable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

The MITRIS RESILIA Mitral Valve is unique because it uses a special tissue technology called RESILIA, which is designed to enhance durability and reduce calcification compared to traditional bioprosthetic valves. Unlike standard mitral valve replacements that may require more frequent interventions due to wear and tear, the RESILIA tissue promises a longer-lasting solution, potentially reducing the need for repeat surgeries. Researchers are excited about this treatment because it holds the potential to improve the quality of life for patients by offering a more resilient and durable valve option, ultimately leading to fewer complications and a longer lifespan for the valve.

What evidence suggests that the MITRIS RESILIA Mitral Valve is effective for mitral valve replacement?

Research shows that the MITRIS RESILIA Mitral Valve effectively replaces damaged mitral valves in the heart. In this trial, patients needing replacement of their native or prosthetic mitral valve will receive the MITRIS RESILIA Mitral Valve. The COMMENCE trial found this valve to be safe and effective. Patients who received it experienced fewer serious heart problems. The valve is durable, lasting a long time without needing replacement. After receiving the valve, patients demonstrated improved heart function, meaning their hearts worked better. ^{6 7 8 9 10}

Who Is on the Research Team?

Gorav Ailawadi, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

Inclusion Criteria

Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery

Provides written informed consent

Willingness to follow protocol requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MITRIS RESILIA Mitral Valve replacement

0 to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• MITRIS RESILIA Mitral Valve, Model 11400M

How Is the Trial Designed?

Group I: Patients requiring replacement of their native or prosthetic mitral valve Experimental Treatment 1 Intervention

Patients requiring replacement of their native or prosthetic mitral valve

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05526560

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ... Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of ...

2. mountsinai.org mountsinai.org/clinical-trials/real-world-clinical-outcomes-of-mitris-resilia-mitral-valve

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ... Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement.

3. eifu.edwards.com eifu.edwards.com/eifu/5d4dd5ad46e0fb0001c61ac7/DOC-0142684E.pdf

MITRIS RESILIA Mitral Valve, Model 11400M The clinical safety and effectiveness of the MITRIS RESILIA mitral valve, model 11400M was established based on the outcome data of the. COMMENCE trial ...

4. trialx.com trialx.com/clinical-trials/listings/230417/real-world-clinical-outcomes-of-the-mitris-resilia-mitral-valve/

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ... Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring ...

5. clinicaltrial.be clinicaltrial.be/en/details/189552?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral... Secondary outcomes 4 · Early rates of major cardiac events · Late linearized rates of major cardiac events · Functional improvement from baseline ...

6. eifu.edwards.com eifu.edwards.com/eifu/5d4dd5ad46e0fb0001c61ac7/DOC-0178065A.pdf

MITRIS RESILIA Mitral Valve, Model 11400M Safety of the MITRIS valve has not been tested in patients with. Nickel allergy. 5.0 Adverse Events. 5.1 Observed Adverse Events. As with all prosthetic heart ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=16850097&pc=LWR

EDWARDS LIFESCIENCES MITRIS RESILIA MITRAL VALVE It was learned through implant patient registry that a 27mm 11400m valve in the mitral position was explanted after an implant duration of 4 months due to ...

8. mayo.edu mayo.edu/research/clinical-trials/cls-20556075

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ... Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects ...

9. eifu.edwards.com eifu.edwards.com/eifu/5d4dd5ad46e0fb0001c61ac7/DOC-0232004A.pdf

MITRIS RESILIA Mitral Valve, Model 11400M A study is being conducted to gather long-term (8-years) safety and performance data on the Carpentier-Edwards. PERIMOUNT Magna Mitral/Magna Mitral Ease valves.

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05526560

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral ... Study Overview. Brief Summary. Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve ...