NCT07069673 · Abbott Medical Devices
Abbott Cephea Mitral Valve Disease Registry
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
- New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV.
- 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.
- Age 18 years or older at time of consent.
- The subject agrees to the study requirements, permits all follow-up data entry, and has provided written informed consent.
Exclusion criteria
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- Subject is undergoing dialysis or experiencing chronic renal failure
- Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral steroid use
- Subjects with comorbidities that are likely to result in a life expectancy of less than 12 months.
- Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
Where
- Birmingham, Alabama
- Phoenix, Arizona
- Thousand Oaks, California
- Atlanta, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Wichita, Kansas
- Minneapolis, Minnesota
- Missoula, Montana
- Roslyn, New York
- The Bronx, New York
- Charlotte, North Carolina
And 7 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations