MITRIS RESILIA Mitral Valve for Mitral Valve Disease
(MOMENTIS Trial)
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.12345Why 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.678910
Who Is on the Research Team?
Gorav Ailawadi, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the MITRIS RESILIA Mitral Valve replacement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MITRIS RESILIA Mitral Valve, Model 11400M
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients requiring replacement of their native or prosthetic mitral valve
Find a Clinic Near You
Who Is Running the Clinical Trial?
Edwards Lifesciences
Lead Sponsor
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
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-valveReal-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.
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 ...
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 ...
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=LWREDWARDS 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 ...
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 ...
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.
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 ...
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