Abbott Cephea Mitral Valve Disease Registry

Recruiting now

Conditions studied: Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Annulus Calcification, Mitral Valve Replacement, Transcatheter Valve Replacement

In brief

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.

Key facts

Study ID

NCT07069673

Run by

Abbott Medical Devices

People needed

1000

Starts

2025-08-13

Expected to finish

2028-12-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
• New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
• 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.
• Age 18 years or older at time of consent.
• The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.

You may not qualify if…

• Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
• Subject is undergoing dialysis or experiencing chronic renal failure
• Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
• Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
• Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.

Where it is running

• University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States (enrolling)
• Phoenix Cardiovascular Research Group — Phoenix, Arizona, United States (enrolling)
• Los Robles Regional Medical Center — Thousand Oaks, California, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (enrolling)
• Ascension St. Vincent — Indianapolis, Indiana, United States (enrolling)
• Via Christi Regional Medical Center - St. Francis Campus — Wichita, Kansas, United States (enrolling)
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States (enrolling)
• Providence St. Patrick Hospital — Missoula, Montana, United States (enrolling)
• St. Francis Hospital — Roslyn, New York, United States (enrolling)
• Montefiore Medical Center - Moses Campus — The Bronx, New York, United States (enrolling)
• Atrium Health - Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Allegheny General Hospital - ASRI — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• TriStar Centennial Medical Center — Nashville, Tennessee, United States (enrolling)
• Ascension Saint Thomas — Nashville, Tennessee, United States (enrolling)
• Vanderbilt Heart & Vascular Institute — Nashville, Tennessee, United States (enrolling)
• Houston Methodist — Houston, Texas, United States (enrolling)
• UTHealth Memorial Hermann — Houston, Texas, United States (enrolling)
• Intermountain Medical Center — Murray, Utah, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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