Cephea Early Feasibility Study

a study on Mitral Valve Insufficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Jason Rogers (ucdavis)

Description

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.

Keywords

Mitral Regurgitation, Mitral Valve Insufficiency, Cephea Mitral Valve System

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

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

Locations

  • University of California - Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Lead Scientist at University of California Health

  • Jason Rogers (ucdavis)
    Associate Physician, MED: Int Med Cardiology (Sac), School of Medicine. Authored (or co-authored) 150 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT05061004
Study Type
Interventional
Participants
Expecting 50 study participants
Last Updated