Abbott Cephea registry for mitral valve disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational registry enrolling adults with symptomatic mitral valve disease, including mitral regurgitation, mitral stenosis, or mixed disease. Sites will record clinical characteristics, treatment decisions, and follow-up outcomes for patients considered appropriate for transcatheter mitral valve replacement with the Cephea system. Enrollment targets patients with NYHA class II–IV symptoms where the heart team favors transcatheter therapy over conventional surgery and where TMVR is expected to be preferable to leaflet repair. Collected data are intended to inform clinical understanding of outcomes after valve correction and to support future regulatory or reimbursement submissions for the Cephea device.

Why it matters

Who can join: the full rules

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.

Where it's running

• University Hospital - Univ. of Alabama at Birmingham (UAB)
  Birmingham, Alabama, United States Recruiting
• Banner-University Medical Center Phoenix
  Phoenix, Arizona, United States Recruiting
• Phoenix Cardiovascular Research Group
  Phoenix, Arizona, United States Recruiting
• Los Robles Regional Medical Center
  Thousand Oaks, California, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Study coordinator: Cephea Project Manager
• Email: cepheamvdregistry@abbott.com
• Phone: 1+612.816.4605

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Left atrial shunt to help after mitral valve surgery

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• Observational registry for patients treated with the NeoChord Artificial Chordae System

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.