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RecruitingNCT07069673Updated Sep 10, 2026

Abbott Cephea Mitral Valve Disease Registry

An observational study in Mitral Regurgitation, Mitral Stenosis and Mitral Valve Disease, sponsored by Abbott Medical Devices. Recruiting at 24 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Abbott Medical Devices (part of Abbott) · Observational

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Mitral Valve Disease
  • registry
  • Cephea Mitral Valve System
03

In context

Mitral Valve Insufficiency

468 studies on the registry are indexed under Mitral Valve Insufficiency; 164 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 157 across 168 observational studies indexed under Mitral Valve Insufficiency.

Browse Mitral Valve Insufficiency studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.

Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Symptomatic mitral valve disease resulting in mitral regurgitation and/or severe mitral valve stenosis.
  2. (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, permits all follow-up data entry, and has provided written .

Exclusion criteria

Exclusion Criteria:

  1. Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  2. Subject is undergoing dialysis or experiencing chronic renal failure
  3. Subject has chronic lung disease requiring continuous home oxygen therapy or chronic outpatient oral use
  4. Subjects with comorbidities that are likely to result in a of less than 12 months.
  5. Pregnant or nursing subjects and those who plan pregnancy during the follow-up period.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • Potential transcatheter mitral valve replacement (TMVR) candidates

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

06

What researchers measure

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

    Time frame: From enrollment to 2 years of follow-up

07

Study locations

24 of 24 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2025 (actual). Primary completion is estimated for Dec 2028, 40 months after the start.

Of 84 observational studies under Mitral Valve Insufficiency, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 192. This study's planned 40 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 23, 2025
First posted
Jul 17, 2025
StartActual
Aug 13, 2025
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07069673
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Aug 13, 2025
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Sep 10, 2026

Study contacts

Cephea Project Manager
Contact
cepheamvdregistry@abbott.com
1+612.816.4605

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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