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Cephea Early Feasibility Study

RECRUITINGN/ASponsored by Abbott Medical Devices
Actively Recruiting
PhaseN/A
SponsorAbbott Medical Devices
Started2022-04-28
Est. completion2026-12-31
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations20 sites
View on ClinicalTrials.gov →

NCT05061004

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Key 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.

Key Exclusion Criteria:

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

Conditions2

Heart DiseaseMitral Regurgitation

Locations20 sites

Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
Paul Sorajja, MD
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Andjela Kremenovic417-353-7177Andjela.Kremenovic@cshs.org
University of California - Davis Medical Center
Sacramento, California, 95817
Heather Houston916-734-5155hhouston@ucdavis.edu
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Mane Arabyan805-796-3746Mane.arabyan@hcahealthcare.com
Emory University Hospital
Atlanta, Georgia, 30308
Elizabeth Charles404-686-1249elizabeth.z.charles@emory.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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