Home › Trials › NCT07069673

Abbott Cephea registry for mitral valve disease

Abbott Cephea Mitral Valve Disease Registry

Observational Abbott Medical Devices · NCT07069673

Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.

Quick facts

Study typeObservational
Enrollment1000 (estimated)
Ages18 Years and up
SexAll
SponsorAbbott Medical Devices Industry-sponsored
Locations22 sites (Phoenix, Arizona and 21 other locations)
Trial IDNCT07069673 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (age 18+) with symptomatic mitral valve disease (regurgitation and/or severe stenosis), NYHA class II–III or ambulatory IV, who the site heart team judges are better served by transcatheter therapy and are candidates for TMVR rather than surgical repair or TEER.

Not a fit: Patients with prior surgical or interventional treatments that interfere with Cephea delivery or function, those on dialysis or with chronic renal failure, or those with chronic lung disease requiring continuous home oxygen are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the registry could improve understanding of which patients benefit from transcatheter mitral valve replacement and support wider access to the Cephea device.

How similar studies have performed: Other registries and early studies of transcatheter mitral valve replacement devices have shown promising early results, but larger comparative and long-term data remain limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Phoenix, Arizona and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Mitral RegurgitationMitral StenosisMitral Valve DiseaseMitral Valve RegurgitationMitral Annulus CalcificationMitral Valve ReplacementTranscatheter Valve Replacementregistry
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.