Abbott Cephea Mitral Valve Disease Registry

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Mitral Annulus Calcification Mitral Stenosis Mitral Valve (MV) Regurgitation Mitral Valve Disease Mitral Valve Insufficiency Mitral Valve Replacement Mitral Valve Stenosis Transcatheter Valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Primary Objective

Time frame: From enrollment to 2 years of follow-up

The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning

Study contacts

Contact information is provided by the study sponsor or research team.

Cephea Project Manager

CONTACT

[email protected]

1+612.816.4605

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2028
First posted: Jul 17, 2025
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting