NCT07069673 Abbott Cephea Mitral Valve Disease Registry
| NCT ID | NCT07069673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Mitral Regurgitation |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2025-08-13 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2025-08-13 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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, 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07069673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mitral Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07069673 currently recruiting?
Yes, NCT07069673 is actively recruiting participants. Contact the research team at cepheamvdregistry@abbott.com for enrollment information.
Where is the NCT07069673 trial being conducted?
This trial is being conducted at Birmingham, United States, Phoenix, United States, Thousand Oaks, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT07069673 clinical trial?
NCT07069673 is sponsored by Abbott Medical Devices. The trial plans to enroll 1,000 participants.