NCT07069673ClinicalTrials.gov

Abbott Cephea Mitral Valve Disease Registry

RecruitingTaking participants now, according to the registry record.

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In brief

Observational1,000 participants sought24 sites1 country

Registered in 1 registry

ClinicalTrials.govNCT07069673Open this record at ClinicalTrials.govSynced 2 weeks ago

One study can be registered in several registries. We show it once and link every record we hold.

Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2025-07-17; recorded start 2025-08-13
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Not stated: Whether participants are randomly assigned is not stated in the registry recordNo allocation method is recorded
Not stated: A comparison group is not stated in the registry recordThe record describes a single study arm
Not stated: Whether the study is blinded is not stated in the registry recordNo masking information is recorded
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 82 other studies in this databaseCounted from the lead sponsor named in the record (Abbott Medical Devices)
Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database

The record lists 7 conditions.
Lead sponsor type recorded as: industry.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourEXPLORATORY

An exploratory-stage design for a study of this type, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation0/20
Allocation not stated in the record
Blinding0/20
Masking not stated in the record
Control arm0/15
No comparator arm stated in the record
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre8/8
Multi-centre: 23 sites
Data monitoring committee0/7
No data monitoring committee stated
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleLARGE

A large study: 1,000 participants (target), run at 24 sites.

How this score is built

Enrolment30/40
1,000 participants (target)
Site count16/25
23 sites
Country count0/15
Single country
Planned duration8/10
Planned over about 40 months
Sponsor scale7/10
Abbott Medical Devices has led 83 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

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.

Conditions

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

Eligibility

Eligibility
Sex	All
Ages	18 Years – No maximum
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.

Eligibility as written in the registry

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, permits all follow-up data entry, 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 dialysis or experiencing chronic renal failure 3. Subject has chronic lung disease 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.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Observational
Phase	Not stated in the registry record
Allocation	Not stated in the registry record
Intervention model	Not stated in the registry record
Primary purpose	Not stated in the registry record
Masking	Not stated in the registry record
Enrolment	1,000 participants sought

Sponsor and collaborators

Abbott Medical Devices Sponsor

Arms and interventions

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

Outcome measures

Primary outcome
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

Dates

Dates
Start date	August 13, 2025 (actual)
Primary completion	December 1, 2028 (estimated)
Completion	December 1, 2028 (estimated)
First posted	July 17, 2025 (actual)
Last updated	September 10, 2026
Results posted	Not stated in the registry record
Status last verified	June 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

24 sites are recruiting

United States

United States
Facility	City	State or region	Status
Piedmont Heart Institute	Atlanta	Georgia	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
University Hospital - Univ. of Alabama at Birmingham (UAB)	Birmingham	Alabama	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Atrium Health - Carolinas Medical Center	Charlotte	North Carolina	Recruiting
Northwestern Memorial Hospital	Chicago	Illinois	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
Houston Methodist	Houston	Texas	Recruiting
UTHealth Memorial Hermann	Houston	Texas	Recruiting
Ascension St. Vincent	Indianapolis	Indiana	Recruiting
Minneapolis Heart Institute	Minneapolis	Minnesota	Recruiting
Providence St. Patrick Hospital	Missoula	Montana	Recruiting
Intermountain Medical Center	Murray	Utah	Recruiting
Ascension Saint Thomas	Nashville	Tennessee	Recruiting
Vanderbilt Heart & Vascular Institute	Nashville	Tennessee	Recruiting
TriStar Centennial Medical Center	Nashville	Tennessee	Recruiting
Sentara Norfolk General Hospital	Norfolk	Virginia	Recruiting
Banner-University Medical Center Phoenix	Phoenix	Arizona	Recruiting
Phoenix Cardiovascular Research Group	Phoenix	Arizona	Recruiting
Allegheny General Hospital - ASRI	Pittsburgh	Pennsylvania	Recruiting
St. Francis Hospital	Roslyn	New York	Recruiting
Montefiore Medical Center - Moses Campus	The Bronx	New York	Recruiting
Los Robles Regional Medical Center	Thousand Oaks	California	Recruiting
Ascension Via Christi Hospitals Wichita	Wichita	Kansas	Recruiting

Study documents

No documents are linked in this registry record.

Changes over time

September 10, 2026
Site added
1 site added (24 total)
2324

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07069673

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Study population

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Outcome measures

Dates

Locations

United States

Study documents

Changes over time