Cephea Early Feasibility Study

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.

Conditions

Mitral Regurgitation

Study Overview

Study Details

Study overview

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.

Cephea Early Feasibility Study

Cephea Early Feasibility Study

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Sacramento

University of California - Davis Medical Center, Sacramento, California, United States, 95817

Atlanta

Piedmont Heart Institute, Atlanta, Georgia, United States, 30309

Wichita

Cardiovascular Research Institute of Kansas, Wichita, Kansas, United States, 67226

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Minneapolis

Minneapolis Heart Institute, Minneapolis, Minnesota, United States, 55407

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

Charlotte

Carolinas Medical Center, Charlotte, North Carolina, United States, 28203

Cleveland

The Cleveland Clinic Foundation, Cleveland, Ohio, United States, 44195

Nashville

St. Thomas Hospital, Nashville, Tennessee, United States, 37205

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Barathi Sethuraman, STUDY_DIRECTOR, Abbott Structural Heart

Study Record Dates

2031-03-01