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NCT07069673Recruiting

Abbott Cephea Mitral Valve Disease Registry

Abbott Medical Devices

Start Date

8/13/2025

Completion Date

12/1/2028

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

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral 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 more appropriate than conventional mitral valve surgery, TMVR is more likely to provide an optimal result than TEER, and the subject has been adequately treated per applicable standards, including for coronary artery disease, left ventricular dysfunction, 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, and has provided written informed consent. Exclusion Criteria: 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function. 2. Subject is undergoing dialysis or experiencing chronic renal failure 3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use 4. Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months. 5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

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Conditions

Mitral RegurgitationMitral StenosisMitral Valve DiseaseMitral Valve (MV) RegurgitationMitral Annulus CalcificationMitral Valve ReplacementTranscatheter Valve Replacement

Locations

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama 35233

United States

Phoenix Cardiovascular Research Group

Phoenix, Arizona 85016

United States

Los Robles Regional Medical Center

Thousand Oaks, California 91360

United States

Piedmont Heart Institute

Atlanta, Georgia 30309

United States

Emory University Hospital

Atlanta, Georgia 30322

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

Ascension St. Vincent

Indianapolis, Indiana 46240

United States

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas 67214

United States

Minneapolis Heart Institute

Minneapolis, Minnesota 55407

United States

Providence St. Patrick Hospital

Missoula, Montana 59802

United States

St. Francis Hospital

Roslyn, New York 11576

United States

Montefiore Medical Center - Moses Campus

The Bronx, New York 10467

United States

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina 28203

United States

The Cleveland Clinic Foundation

Cleveland, Ohio 44195

United States

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania 15212

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

TriStar Centennial Medical Center

Nashville, Tennessee 37203

United States

Ascension Saint Thomas

Nashville, Tennessee 37205

United States

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee 37232

United States

Houston Methodist

Houston, Texas 77030

United States

UTHealth Memorial Hermann

Houston, Texas 77030

United States

Intermountain Medical Center

Murray, Utah 84107

United States

Sentara Norfolk General Hospital

Norfolk, Virginia 23507

United States