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NCT04919980 · ClinicalTrials.gov registry record · NA
TVMR With the INNOVALVE System Trial - Early Feasibility Study
A NA study of Mitral Valve Regurgitation (Degenerative or Functional), sponsored by Edwards Lifesciences.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 17
- Study locations
NCT04919980: Recruiting NA study of Mitral Valve Regurgitation (Degenerative or Functional), sponsored by Edwards Lifesciences.
NCT04919980 is a NA study of Mitral Valve Regurgitation (Degenerative or Functional) that is actively recruiting participants, run by Edwards Lifesciences. The registered enrollment target is 65 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919980, a NA study of Mitral Valve Regurgitation (Degenerative or Functional), is actively recruiting participants, sponsored by Edwards Lifesciences.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 17
- Study locations
Study Summary
Study to evaluate the safety and performance of the INNOVALVE system
Primary Outcome
Absence of implant or delivery related serious adverse events
Conditions Studied
Interventions
- DEVICE INNOVALVE system
Study Locations (17)
New York
- Northwell Health - Manhasset
- Cornell - New York
- NewYork-Presbyterian / Columbia University - New York
Ohio
- Cleveland Clinic - Cleveland
- OhioHealth Research Institute - Columbus
Tennessee
- Vanderbilt University Medical Center - Nashville
- Ascension Saint Thomas - Nashville
California
- Cedars-Sinai - Los Angeles
Florida
- Naples Comprehensive Health - Naples
Georgia
- Piedmont Heart Institute - Atlanta
Illinois
- Northwestern - Chicago
Michigan
- University of Michigan Hospital and Health Systems - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2022-09-01 |
| Est. Completion | 2031-07-01 |
| Phase | NA |
What NCT04919980 shows while recruiting
NCT04919980 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Mitral Valve Regurgitation (Degenerative or Functional) appearing as the primary indexed condition, and to 1 intervention - of which INNOVALVE system is the first listed.
NCT04919980 lists 17 locations in 13 states (New York, Ohio, Tennessee).
Frequently Asked Questions
What is clinical trial NCT04919980 about?
NCT04919980 is a clinical study titled "TVMR With the INNOVALVE System Trial - Early Feasibility Study". Study to evaluate the safety and performance of the INNOVALVE system
What is the current status of trial NCT04919980?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2022-09-01. Estimated completion is 2031-07-01.
What conditions does trial NCT04919980 study?
This clinical trial studies the following conditions: Mitral Valve Regurgitation (Degenerative or Functional).
What interventions are being tested in trial NCT04919980?
The interventions under investigation include: INNOVALVE system (DEVICE).
Who is sponsoring clinical trial NCT04919980?
This trial is sponsored by Edwards Lifesciences, which has 57 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919980 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04919980's enrollment target sits among peer trials
65 1145th of 2000 higher than 854 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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