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Prosthetic Heart Valve

Patients requiring replacement of their native or prosthetic mitral valve for Mitral Valve Stenosis (MOMENTIS Trial)

N/A
Recruiting
Led By Gorav Ailawadi, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, 5, 8, and 10 years post implant
Awards & highlights

Summary

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 their native or prosthetic mitral valve with or without concomitant procedures.

Eligible Conditions
  • Mitral Valve Stenosis
  • Mitral Valve Regurgitation

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, 5, 8, and 10 years post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 3, 5, 8, and 10 years post implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Freedom from valve related death or valve related reintervention
Hemodynamic performance as measured by peak and mean gradient by echocardiography
Secondary outcome measures
Early rates of major cardiac events
Functional improvement from baseline for New York Heart Association (NYHA) Class
Improvement from baseline for Quality of Life
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients requiring replacement of their native or prosthetic mitral valveExperimental Treatment1 Intervention
Patients requiring replacement of their native or prosthetic mitral valve

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,541 Total Patients Enrolled
2 Trials studying Mitral Valve Stenosis
902 Patients Enrolled for Mitral Valve Stenosis
Gorav Ailawadi, MDPrincipal InvestigatorUniversity of Michigan
3 Previous Clinical Trials
1,838 Total Patients Enrolled
~331 spots leftby Jan 2028
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