Abbott Cephea Mitral Valve Disease Registry

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Aug 13, 2025

Status verified

Oct 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

1,000 participants (estimated)

Arms

• Arm: Potential transcatheter mitral valve replacement (TMVR) candidates
  Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.

Primary Outcome Measure

Primary Objective [ Time Frame: From enrollment to 2 years of follow-up ]

Central Contacts

• Cephea Project Manager
  1+612.816.4605
  [email protected]

Locations (22)

Find similar trials in Phoenix, AZ

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