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Cephea Early Feasibility Study | Clinical Trials | Clareo Health

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RECRUITINGNANCT05061004

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 mit...

Lead sponsor: Abbott Medical Devices•20 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Leslie Centeno

CONTACT

+1 818-294-3041 leslie.centeno@abbott.com

Clinical Project Manager

CONTACT

Cephea_FS@abbott.com

Sponsors

Lead Sponsor

Abbott Medical Devices

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
•LVEF ≥ 30%
•In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Exclusion Criteria

•Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
•Need for emergent or urgent surgery.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 8, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment50

Start dateApr 2022

Last updatedApr 8, 2026

Condition

Mitral Regurgitation

Locations shown

Banner-University Medical Center Phoenix

Phoenix, Arizona

Cedars-Sinai Medical Center

Los Angeles, California

University of California - Davis Medical Center

Sacramento, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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