RecruitingNCT05061004

Cephea Early Feasibility Study

Abbott Medical DevicesMultiple US sitesView on ClinicalTrials.gov

AI Description

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.

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Who can join
adult, older adult
Participants
90
Expected completion
2031-03-01
Funded by
industry

Conditions studied

Mitral Regurgitation

What is being tested

  • DEVICE: Cephea Mitral Valve System

What it measures

  • Primary Effectiveness Endpoint, Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant., 30 days post implant
  • Primary Safety Endpoint, Freedom from all-cause mortality, which will be assessed at 30 days post implant., 30 days post implant

Centers Participating

These centers are participating in this study. Reach out to them directly to learn more.

Data Sources and Methodology

Registry entry updated 2026-09-11

Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.

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