Abbott Cephea Mitral Valve Disease Registry

Abbott

Status: Not yet enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT07069673

ABT-CIP-10593

Details and patient eligibility

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. 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Potential transcatheter mitral valve replacement (TMVR) candidates

Description:

Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.