RECRUITING

Abbott Cephea Mitral Valve Disease Registry

Description

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.

Conditions

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

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

Study Overview

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Study Details

Study overview

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.

Abbott Cephea Mitral Valve Disease Registry

Abbott Cephea Mitral Valve Disease Registry

Condition
Mitral Regurgitation
Intervention / Treatment

-

Contacts and Locations

Wichita

Via Christi Regional Medical Center - St. Francis Campus, Wichita, Kansas, United States, 67214

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 and to return for all required follow-up visits, and has provided written informed consent.
  • 1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  • 2. Subject is undergoing hemodialysis or experiencing chronic renal failure
  • 3. Subject has COPD 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Study Record Dates

2028-12