Abbott Cephea Mitral Valve Disease Registry

Recruiting

• Conditions: Mitral Regurgitation; Mitral Stenosis; Mitral Valve Disease; Mitral Valve (MV) Regurgitation; Mitral Annulus Calcification; Mitral Valve Replacement; Transcatheter Valve Replacement

• Registration Number: NCT07069673
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-07-07
• Study First Posted: 2025-07-17
• Status Verified: 2025-08
• Study Start: 2025-08-13
• Last Update Submitted: 2025-08-16
• Last Update Posted: 2025-08-19
• Primary Completion: 2028-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective	From enrollment to 2 years of follow-up	The objective of the MVD Registry is to collect data on the progression of MVD patients considered for TMVR therapy to guide product development, regulatory submissions, and reimbursement planning

Trial Locations

Locations (1)

Via Christi Regional Medical Center - St. Francis Campus; 🇺🇸 Wichita, Kansas, United States