Abbott Cephea Mitral Valve Disease Registry

Launched by ABBOTT MEDICAL DEVICES · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is gathering information about people who have problems with their mitral valve, a part of the heart that helps control blood flow. The trial focuses on patients who have symptoms caused by conditions like mitral valve leakage (regurgitation) or narrowing (stenosis). The goal is to learn more about how treating these problems with a newer, less invasive procedure called Transcatheter Mitral Valve Replacement (TMVR) affects patients’ health and quality of life. This information may help doctors and hospitals improve care and support future approval and insurance coverage for the treatment.

People who might be eligible for this study are adults with symptoms that affect their daily activities and who have been evaluated by heart specialists as better candidates for TMVR than traditional surgery. To join, patients need to have moderate to severe mitral valve issues causing symptoms, be medically stable enough for the procedure, and agree to follow-up visits. However, those who have had certain previous heart treatments, have serious kidney or lung problems, or other health issues limiting life expectancy may not qualify. Participants will be closely monitored after the procedure to track how well the treatment works and how it affects their overall health.

Gender

ALL

Eligibility 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 and to return for all required follow-up visits, 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 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.