Abbott Cephea Mitral Valve Disease Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-13

Study Completion Date

2028-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Mitral Regurgitation Mitral Stenosis Mitral Valve Disease Mitral Valve (MV) Regurgitation Mitral Annulus Calcification Mitral Valve Replacement Transcatheter Valve Replacement

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Potential transcatheter mitral valve replacement (TMVR) candidates

Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No