Abbott Cephea Mitral Valve Disease Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Primary Objective [Time frame: From enrollment to 2 years of follow-up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 23 centers
- University Hospital - Univ. of Alabama at Birmingham (UAB) — Birmingham
- Phoenix Cardiovascular Research Group — Phoenix
- Los Robles Regional Medical Center — Thousand Oaks
- Piedmont Heart Institute — Atlanta
- Emory University Hospital — Atlanta
- Northwestern Memorial Hospital — Chicago
- Ascension St. Vincent — Indianapolis
- Via Christi Regional Medical Center - St. Francis Campus — Wichita
- … and 15 more centers
Identifiers
NCT: NCT07069673 · ABT-CIP-10593