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ACTIVE NOT RECRUITING

Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve

NCT05526560 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DEVICE MITRIS RESILIA Mitral Valve, Model 11400M

Study Locations (20)

New York

  • Mount Sinai Hospital — New York
  • Columbia University Irving Medical Center — New York
  • Weill Cornell Medicine — New York

Pennsylvania

  • Hospital of the University of Pennsylvania — Philadelphia
  • Allegheny General Hospital — Pittsburgh
  • UPMC Presbyterian Shadyside — Pittsburgh

California

  • Hoag Memorial Hospital Presbyterian — Newport Beach
  • Stanford University — Palo Alto

Georgia

  • Piedmont Heart Institute — Athens
  • Piedmont Heart Institute — Atlanta

Tennessee

  • Tristar Centennial Medical Center — Nashville
  • Ascension Saint Thomas — Nashville

Florida

  • AdventHealth Orlando — Orlando

Indiana

  • Ascension St. Vincent Heart Center — Carmel

Michigan

  • University of Michigan — Ann Arbor

Trial Details

FieldValue
Enrollment Target 504 participants
Start Date 2023-01-11
Est. Completion 2035-12

Sponsor

Edwards Lifesciences

34 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05526560

The ClinicalTrials.gov registry entry for NCT05526560 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 504 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edwards Lifesciences, which has 34 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Mitral Valve Insufficiency appearing as the primary indexed condition, and to 1 intervention — of which MITRIS RESILIA Mitral Valve, Model 11400M is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05526560 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05526560 about?

NCT05526560 is a clinical study titled "Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve". 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.

What is the current status of trial NCT05526560?

This trial is currently active not recruiting. The enrollment target is 504 participants. The study started on 2023-01-11. Estimated completion is 2035-12.

What conditions does trial NCT05526560 study?

This clinical trial studies the following conditions: Mitral Valve Insufficiency, Mitral Stenosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05526560?

The interventions under investigation include: MITRIS RESILIA Mitral Valve, Model 11400M (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05526560?

This trial is sponsored by Edwards Lifesciences, which has 34 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05526560 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Indiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial