Abbott Cephea Mitral Valve Disease Registry
1 other identifier
observational
1,000
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2025
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedStudy Start
First participant enrolled
August 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 11, 2026
October 1, 2025
3.3 years
June 23, 2025
March 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Objective
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
From enrollment to 2 years of follow-up
Study Arms (1)
Potential transcatheter mitral valve replacement (TMVR) candidates
Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement.
Eligibility Criteria
This registry will enroll subjects over 18 years of age of all genders with symptomatic mitral valve disease including those with mitral regurgitation, mitral stenosis, and mixed mitral valve disease, who are candidates for transcatheter mitral valve replacement.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85016, United States
Los Robles Regional Medical Center
Thousand Oaks, California, 91360, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Ascension St. Vincent
Indianapolis, Indiana, 46240, United States
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67214, United States
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Providence St. Patrick Hospital
Missoula, Montana, 59802, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
Ascension Saint Thomas
Nashville, Tennessee, 37205, United States
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232, United States
Houston Methodist
Houston, Texas, 77030, United States
UTHealth Memorial Hermann
Houston, Texas, 77030, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 17, 2025
Study Start
August 13, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
March 11, 2026
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will not share