Mitral RegurgitationNCT07069673
Abbott Cephea Mitral Valve Disease Registry
An observational study of Mitral Regurgitation and Mitral Stenosis, run by Abbott Medical Devices at 24 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease
- How many people
- 1,000 participants
- Where
- 24 sitesUnited States
- Study dates
- 13 Aug 2025to Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
United States24 sites, 24 recruiting
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Danielle Griffith, 404-605-2958, Danielle.griffith@piedmont.org
Pradeep Yadav, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Elizabeth Charles, MPH, 404-686-1249, elizabeth.z.charles@emory.edu
Adam Greenbaum, MD
- Recruiting
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, 35233
Katherine Phillips, 205-975-1888, kcphillips@uabmc.edu
Mustafa Ahmed, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Lauren Wakefield, 843-876-5049, wakefila@musc.edu
Daniel Steinberg, MD
- Recruiting
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203
ShaMal Brown, 704-355-4691, shamal.brown@atriumhealth.org
Michael Rinaldi, MD
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Maggie McNamara, 312-926-0846, margaret.mcnamara@nm.org
Anita Asgar, MD
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Emilia Drenkhan, 216-636-0776, drenkhe2@ccf.org
Amar Krishnaswamy, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Laticia Ellankil, lsellankil@houstonmethodist.org
Sachin Goel, MD
- Recruiting
UTHealth Memorial Hermann
Houston, Texas, 77030
Angela Scott, 713-486-6739, Angela.Scott@uth.tmc.edu
Biswajit Kar, MD
- Recruiting
Ascension St. Vincent
Indianapolis, Indiana, 46240
Jena Stanley, BSN, RN, CCRN-K, 317-583-6115, jena.stanley@ascension.org
Ezequiel Munoz, MD
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Jennifer Nguyen, 612-863-9291, jennifer.nguyen@allina.com
Mario Goessl, MD
- Recruiting
Providence St. Patrick Hospital
Missoula, Montana, 59802
Hillary Lapham, 406-327-1835, Hillary.Lapham@providence.org
James Maddux, MD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Lindsay Bosh, 801-917-0978, Lindsay.Bosh@imail.org
Brian Whisenant, MD
- Recruiting
TriStar Centennial Medical Center
Nashville, Tennessee, 37203
Taegan Vinarsky, taegan.vinarsky@hcahealthcare.com
Andrew Goodman, MD
- Recruiting
Ascension Saint Thomas
Nashville, Tennessee, 37205
Sabrina Knight, sabrina.knight@ascension.org
Evelio Rodriguez, MD
- Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37232
Kathryn Adams, kathy.adams@vumc.org
Kashish Goel, MD
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Christine Calayo, RN, 757-388-3876, cacalayo@sentara.com
Matthew Summers, MD
- Recruiting
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
Raelyn McGarry, 602-827-2161, rmcgarry@arizona.edu
Paul Sorajja, MD
- Recruiting
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85016
Jessica Byrne, 602-952-0002, jessicabyrne@pcrg.hush.com
Timothy Byrne, DO, FACC
- Recruiting
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
Kaylea Flick, Kaylea.Flick@ahn.org
Walter McGregor, MD
- Recruiting
St. Francis Hospital
Roslyn, New York, 11576
Elizabeth Haag, RN, BSN, CCRP, 516-562-6790, Elizabeth.Haag@chsli.org
William Chung, MD
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Anna Wielgat, awielgat@montefiore.org
Andrea Scotti, MD
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Jason Yashar, 310-423-0782, Jason.Yashar@HCAHealthcare.com
Saibal Kar, MD
- Recruiting
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214
Lindsey Steele, 316-268-8092, lindsey.steele@ascension.org
Bassem Chehab, MD
About this study
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
- Keywords
- Mitral Valve Disease, registry, Cephea Mitral Valve System
- Medical subject headings
- Mitral Valve Insufficiency, Mitral Valve Stenosis, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Potential transcatheter mitral valve replacement (TMVR) candidates | Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 2 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start13 Aug 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069673
- Sponsor's protocol ID
- ABT-CIP-10593
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Cephea Mitral Valve Disease Registry
- ClinicalTrials.gov ID
- NCT07069673
- Acronym / sponsor ID
- ABT-CIP-10593
- Conditions
- Mitral Regurgitation, Mitral Stenosis, Mitral Valve Disease, Mitral Valve (MV) Regurgitation, Mitral Annulus Calcification, Mitral Valve Replacement
- Keywords
- Mitral Valve Disease, registry, Cephea Mitral Valve System
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potential transcatheter mitral valve replacement (TMVR) candidates | – | –Patients with symptomatic mitral valve disease who may be candidates for transcatheter mitral valve replacement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Objective
Time frame: From enrollment to 2 years of follow-up
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Regurgitation and Mitral Stenosis, run by Abbott Medical Devices at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cephea Project Manager (1+612.816.4605, cepheamvdregistry@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Objective (time frame: From enrollment to 2 years of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.