Cephea Early Feasibility Study

  • End date
    Jan 1, 2028
  • participants needed
  • sponsor
    Abbott Medical Devices
Updated on 7 October 2022
Madeline DeMonte
Primary Contact
Minneapolis Heart Institute (3.2 mi away) Contact
+9 other location
heart surgery
mitral valve replacement


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 regurgitation ≥ Grade III in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Condition Mitral Regurgitation
Treatment Cephea Mitral Valve System
Clinical Study IdentifierNCT05061004
SponsorAbbott Medical Devices
Last Modified on7 October 2022


Yes No Not Sure

Inclusion Criteria

Mitral regurgitation ≥ Grade III 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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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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