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NCT05061004 · ClinicalTrials.gov registry record · NA
Cephea Early Feasibility Study
A NA study of Mitral Regurgitation, sponsored by Abbott Medical Devices.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT05061004: Recruiting NA study of Mitral Regurgitation, sponsored by Abbott Medical Devices.
NCT05061004 is a NA study of Mitral Regurgitation that is actively recruiting participants, run by Abbott Medical Devices. The registered enrollment target is 50 participants, below the 1,022-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05061004, a NA study of Mitral Regurgitation, is actively recruiting participants, sponsored by Abbott Medical Devices.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.
Primary Outcome
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Conditions Studied
Interventions
- DEVICE Cephea Mitral Valve System
Study Locations (20)
California
- Cedars-Sinai Medical Center - Los Angeles
- University of California - Davis Medical Center - Sacramento
- Los Robles Regional Medical Center - Thousand Oaks
Georgia
- Emory University Hospital - Atlanta
- Piedmont Heart Institute - Atlanta
New York
- New York-Presbyterian/Columbia University Medical Center - New York
- Montefiore Medical Center - Moses Campus - The Bronx
Tennessee
- Ascension Saint Thomas - Nashville
- Vanderbilt Heart & Vascular Institute - Nashville
Arizona
- Banner-University Medical Center Phoenix - Phoenix
Illinois
- Northwestern Memorial Hospital - Chicago
Kansas
- Via Christi Regional Medical Center - St. Francis Campus - Wichita
Michigan
- University of Michigan - Davis Medical Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-04-28 |
| Est. Completion | 2031-03-01 |
| Phase | NA |
What NCT05061004 shows while recruiting
NCT05061004 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,022-participant average among 26 other Mitral Regurgitation trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Mitral Regurgitation appearing as the primary indexed condition, and to 1 intervention - of which Cephea Mitral Valve System is the first listed.
NCT05061004 names 20 study sites across 15 states, led by California, Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT05061004 about?
NCT05061004 is a clinical study titled "Cephea Early Feasibility Study". The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is ...
What is the current status of trial NCT05061004?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-04-28. Estimated completion is 2031-03-01.
What conditions does trial NCT05061004 study?
This clinical trial studies the following conditions: Mitral Regurgitation.
What interventions are being tested in trial NCT05061004?
The interventions under investigation include: Cephea Mitral Valve System (DEVICE).
Who is sponsoring clinical trial NCT05061004?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05061004 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mitral Regurgitation
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 NCT05061004's enrollment target sits among peer trials
50 19th of 26 higher than 7 of 26 other Mitral Regurgitation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mitral Regurgitation 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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An Early Feasibility Study of the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement System
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The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).
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