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NCT05526560 · ClinicalTrials.gov registry record
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
A clinical trial of Mitral Valve Insufficiency and Mitral Stenosis, sponsored by Edwards Lifesciences.
- Active
- Registry status
- 504
- Enrollment target
- 20
- Study locations
NCT05526560: Active study of Mitral Valve Insufficiency and Mitral Stenosis, sponsored by Edwards Lifesciences.
NCT05526560 is a study of Mitral Valve Insufficiency and Mitral Stenosis that is active but no longer recruiting, run by Edwards Lifesciences. The registered enrollment target is 504 participants, above the 340-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (48% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05526560, a study of Mitral Valve Insufficiency and Mitral Stenosis, is active but no longer recruiting, sponsored by Edwards Lifesciences.
- ACTIVE NOT RECRUITING
- Registry status
- 504 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 504 participants |
| Start Date | 2023-01-11 |
| Est. Completion | 2035-12 |
What the registry record for NCT05526560 still lists
NCT05526560 is an observational study that tracks outcomes without assigning an intervention. The registered 504 participants enrollment target is mid-sized for trials with a published cap, above the 340-participant average among 11 other Mitral Valve Insufficiency trials with a reported enrollment target (48% higher).
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.
NCT05526560 names 20 study sites across 13 states, led by New York, Pennsylvania, California.
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.
What interventions are being tested in trial NCT05526560?
The interventions under investigation include: MITRIS RESILIA Mitral Valve, Model 11400M (DEVICE).
Who is sponsoring clinical trial NCT05526560?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Mitral Valve Insufficiency
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05526560's enrollment target sits among peer trials
504 4th of 11 higher than 8 of 11 other Mitral Valve Insufficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Valve Insufficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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