Abbott Cephea Mitral Valve Disease Registry

Last updated: March 10, 2026
Sponsor: Abbott Medical Devices
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heartburn (Pediatric)

Esophageal Disorders

Congestive Heart Failure

Treatment

N/A

Clinical Study ID

NCT07069673
ABT-CIP-10593
  • Ages > 18
  • All Genders

Study Summary

The objective of this registry is to gather clinical data on symptomatic patients with mitral valve disease, including patients with mitral regurgitation, mitral stenosis, and mixed mitral valve disease. Data collected from this registry are expected to improve our understanding of the impact of correcting symptomatic mitral valve disease on clinical outcomes in patients that could be candidates for Transcatheter Mitral Valve Replacement and may also inform future regulatory or reimbursement submission strategies for the Cephea Mitral Valve System.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severemitral valve stenosis.

  2. New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.

  3. In the judgement of the Site Heart Team, transcatheter therapy is deemed to be moreappropriate than conventional mitral valve surgery, TMVR is more likely to providean optimal result than TEER, and the subject has been adequately treated perapplicable standards, including for coronary artery disease, left ventriculardysfunction, and heart failure.

  4. Age 18 years or older at time of consent.

  5. The subject agrees to the study requirements, permits all follow-up data entry, andhas provided written informed consent.

Exclusion

Exclusion Criteria:

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

  2. Subject is undergoing dialysis or experiencing chronic renal failure

  3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronicoutpatient oral steroid use

  4. Subjects with comorbidities that are likely to result in a life expectancy of lessthan 12 months.

  5. Pregnant or nursing subjects and those who plan pregnancy during the follow-upperiod.

Study Design

Total Participants: 1000
Study Start date:
August 13, 2025
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Phoenix Cardiovascular Research Group

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Phoenix Cardiovascular Research Group

    Phoenix 5308655, Arizona 5551752 85016
    United States

    Site Not Available

  • Los Robles Regional Medical Center

    Thousand Oaks, California 91360
    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 30322
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta, Georgia 30309
    United States

    Active - Recruiting

  • Emory University Hospital

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Active - Recruiting

  • Piedmont Heart Institute

    Atlanta 4180439, Georgia 4197000 30309
    United States

    Site Not Available

  • Northwestern Memorial Hospital

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Ascension St. Vincent

    Indianapolis, Indiana 46240
    United States

    Active - Recruiting

  • Ascension St. Vincent

    Indianapolis 4259418, Indiana 4921868 46240
    United States

    Site Not Available

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita, Kansas 67214
    United States

    Active - Recruiting

  • Via Christi Regional Medical Center - St. Francis Campus

    Wichita 4281730, Kansas 4273857 67214
    United States

    Site Not Available

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • Providence St. Patrick Hospital

    Missoula, Montana 59802
    United States

    Active - Recruiting

  • Providence St. Patrick Hospital

    Missoula 5666639, Montana 5667009 59802
    United States

    Site Not Available

  • St. Francis Hospital

    Roslyn, New York 11576
    United States

    Active - Recruiting

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York 10467
    United States

    Active - Recruiting

  • Atrium Health - Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Allegheny General Hospital - ASRI

    Pittsburgh, Pennsylvania 15212
    United States

    Active - Recruiting

  • Allegheny General Hospital - ASRI

    Pittsburgh 5206379, Pennsylvania 6254927 15212
    United States

    Site Not Available

  • Ascension Saint Thomas

    Nashville, Tennessee 37205
    United States

    Active - Recruiting

  • TriStar Centennial Medical Center

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Ascension Saint Thomas

    Nashville 4644585, Tennessee 4662168 37205
    United States

    Site Not Available

  • TriStar Centennial Medical Center

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Active - Recruiting

  • Vanderbilt Heart & Vascular Institute

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Active - Recruiting

  • Houston Methodist

    Houston, Texas 77030
    United States

    Active - Recruiting

  • UTHealth Memorial Hermann

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • UTHealth Memorial Hermann

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Sentara Norfolk General Hospital

    Norfolk, Virginia 23507
    United States

    Active - Recruiting

  • Sentara Norfolk General Hospital

    Norfolk 4776222, Virginia 6254928 23507
    United States

    Site Not Available

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