Cephea Early Feasibility Study

Last updated: December 3, 2025
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Mitral Valve Regurgitation

Congestive Heart Failure

Treatment

Cephea Mitral Valve System

Clinical Study ID

NCT05061004
ABT-CIP-10354
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/orsevere mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society ofEchocardiography criteria.

  • LVEF ≥ 30%

  • In the judgement of the Site Heart Team, transcatheter therapy is deemed moreappropriate than open heart surgery.

Exclusion

Key Exclusion Criteria:

  • Prior surgical or interventional treatment that interferes with the Cephea valvedelivery or function.

  • Need for emergent or urgent surgery.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Cephea Mitral Valve System
Phase:
Study Start date:
April 28, 2022
Estimated Completion Date:
March 01, 2031

Connect with a study center

  • Institut de Cardiologie de Montreal

    Montreal, Quebec
    Canada

    Site Not Available

  • Institut de Cardiologie de Montreal

    Montreal 6077243, Quebec 6115047
    Canada

    Completed

  • Institut de Cardiologie de Quebec

    Québec 6325494, Quebec 6115047 G1V 4G5
    Canada

    Site Not Available

  • Institut de Cardiologie de Quebec

    Quebec, G1V 4G5
    Canada

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California - Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360
    United States

    Site Not Available

  • Cedars-Sinai Medical Center

    Los Angeles 5368361, California 5332921 90048
    United States

    Active - Recruiting

  • University of California - Davis Medical Center

    Sacramento 5389489, California 5332921 95817
    United States

    Active - Recruiting

  • Los Robles Regional Medical Center

    Thousand Oaks 5402405, California 5332921 91360
    United States

    Site Not Available

  • Emory University Hospital

    Atlanta, Georgia 30308
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30308
    United States

    Site Not Available

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Cardiovascular Research Institute of Kansas

    Wichita, Kansas 67226
    United States

    Active - Recruiting

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas 67214
    United States

    Site Not Available

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita 4281730, Kansas 4273857 67214
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Minneapolis Heart Institute

    Minneapolis 5037649, Minnesota 5037779 55407
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York-Presbyterian/Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • New York-Presbyterian/Columbia University Medical Center

    New York 5128581, New York 5128638 10032
    United States

    Site Not Available

  • Montefiore Medical Center - Moses Division

    The Bronx 5110266, New York 5128638 10467
    United States

    Active - Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Atrium Health - Carolinas Medical Center

    Charlotte 4460243, North Carolina 4482348 28203
    United States

    Active - Recruiting

  • The Cleveland Clinic Foundation

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • The Cleveland Clinic Foundation

    Cleveland 5150529, Ohio 5165418 44195
    United States

    Active - Recruiting

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Allegheny General Hospital - ASRI

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • St. Thomas Hospital

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37208
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville 4644585, Tennessee 4662168 37208
    United States

    Site Not Available

  • The Methodist Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Methodist

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Site Not Available

  • Swedish Medical Center

    Seattle 5809844, Washington 5815135 98122
    United States

    Site Not Available

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