Who may be eligible for this mitral valve disease clinical trial?

Adults aged 18 or older with symptomatic mitral valve disease causing mitral regurgitation or severe stenosis may be eligible. Participants should be in NYHA Functional Class II, III, or ambulatory IV and considered suitable for transcatheter therapy by their heart team. Please review eligibility criteria for more details.

Is there any cost to participate in this mitral valve disease clinical trial?

Study-related care, including data collection and follow-up, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered by the study.

Actively Recruiting

Age: 18Years +

All Genders

ID07069673

Abbott Cephea Mitral Valve Disease Registry to Collect Data on Patients with Symptomatic Mitral Valve Disease Eligible for Transcatheter Mitral Valve Replacement

Q: What is this study trying to find out about mitral valve disease?

This study aims to gather clinical data to understand the effects of correcting symptomatic mitral valve disease, especially in patients who may be candidates for Transcatheter Mitral Valve Replacement. The research is led by Abbott Medical Devices and seeks to improve knowledge about patient outcomes and support future regulatory decisions.

Led by Abbott Medical Devices · Updated on 2026-05-12

1000

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement TMVR. The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.

CONDITIONS

Brief Title

Abbott Cephea Mitral Valve Disease Registry

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Symptomatic mitral valve disease causing mitral regurgitation and/or severe mitral valve stenosis
New York Heart Association (NYHA) Functional Class II, III, or ambulatory IV
Heart team considers transcatheter therapy more appropriate than conventional surgery and TMVR more likely to succeed than TEER
Age 18 years or older at time of consent
Agreement to study requirements, follow-up data entry, and written informed consent provided

You will not qualify if you...

Prior surgical or interventional treatment interfering with Cephea valve delivery or function
Undergoing dialysis or chronic renal failure
Chronic lung disease needing continuous home oxygen or chronic outpatient oral steroid use
Comorbidities likely to result in life expectancy less than 12 months
Pregnant or nursing, or planning pregnancy during follow-up period

Research Team

Cephea Project Manager

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