Cephea Early Feasibility Study

a study on Mitral Valve Insufficiency

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around
Principal Investigator
by Jason Rogers, MD

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
  • Los Robles Regional Medical Center accepting new patients
    Thousand Oaks California 91360 United States

Lead Scientist at UC Davis

  • Jason Rogers, MD
    Associate Physician, MED: Int Med Cardiology (Sac), School of Medicine. Authored (or co-authored) 158 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
Contact us about this trial