Mitral RegurgitationNCT05061004
Cephea Early Feasibility Study
A study testing Cephea Mitral Valve System in people with Mitral Regurgitation, run by Abbott Medical Devices at 22 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- Cephea Mitral Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 28 Apr 2022to 1 Mar 2031
- Phase
- Interventional
- 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
Who may be able to join
- Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria.
- LVEF ≥ 30%
- In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Who cannot join
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- Need for emergent or urgent surgery.
Trial locations and contacts
22 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Clinical Project Manager contact
22 sites in 2 countries
United States20 sites, 20 recruiting
- Recruiting
University of Michigan - Davis Medical Center
Ann Arbor, Michigan, 48109
Allison Schley, 734-232-4319, schleya@med.umich.edu
Gorav Ailawadi, MD
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30308
Elizabeth Charles, (404) 686-1249, elizabeth.z.charles@emory.edu
Adam Greenbaum, MD
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Danielle Griffith, 404-605-2958, Danielle.griffith@piedmont.org
Vinod Thourani, MD
- Recruiting
Atrium Health - Carolinas Medical Center
Charlotte, North Carolina, 28203
Montana Bright, montana.bright@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
Emily Tylicki, 216-444-6950, tylicke@ccf.org
Samir Kapadia, MD
- Recruiting
Houston Methodist
Houston, Texas, 77030
Deena Victor, dcvictor@HoustonMethodist.org
Sachin Goel, MD
- Recruiting
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Andjela Kremenovic, 417-353-7177, Andjela.Kremenovic@cshs.org
Raj Makkar, MD
- Recruiting
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407
Jennifer Nguyen, 612-863-9291, Jennifer.nguyen@allina.com
Mario Goessl, MD
- Recruiting
Ascension Saint Thomas
Nashville, Tennessee, 37205
Kolie Gasaway, (615) 222-3227, kolie.gasaway@ascension.org
Evelio Rodriguez, MD
- Recruiting
Vanderbilt Heart & Vascular Institute
Nashville, Tennessee, 37208
Kathryn Adams, kathy.adams@vumc.org
Kashish Goel
- Recruiting
New York-Presbyterian/Columbia University Medical Center
New York, New York, 10032
Kate Dalton, 212-342-1820, keb2114@columbia.edu
Torsten Vahl
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Christine Calayo, (757) 388-3876, cacalayo@sentara.com
Matthew Summers, MD
- Recruiting
Banner-University Medical Center Phoenix
Phoenix, Arizona, 85006
Paul Sorajja, MD
- Recruiting
Allegheny General Hospital - ASRI
Pittsburgh, Pennsylvania, 15212
Tracy Spirk, (412) 359-4025, tracy.spirk@ahn.org
Walter McGregor, MD
- Recruiting
University of California - Davis Medical Center
Sacramento, California, 95817
Heather Houston, 916-734-5155, hhouston@ucdavis.edu
Jason Rogers, MD
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Jennifer Nagel, jennifer.nagel@swedish.org
Sameer Gafoor, MD
- Recruiting
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Tammy Rodriguez Guzman, (718) 920-6523, tamrodrigu@montefiore.org
Mohamed Azeem Latib, MD
- Recruiting
Los Robles Regional Medical Center
Thousand Oaks, California, 91360
Mane Arabyan, (805) 796-3746, Mane.arabyan@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
Canada2 sites
- Completed
Institut de Cardiologie de Montreal
Montreal, Quebec
- Withdrawn
IUCPQ-ULaval
Québec, Quebec, G1V 4G5
About this study
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.
- Conditions
- Mitral Regurgitation
- Being tested
- Cephea Mitral Valve System
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephea Mitral Valve SystemDevice
Transcatheter mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System Receives: Device: Cephea Mitral Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Measured: 30 days post implant
Primary Effectiveness Endpoint
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
Measured: 30 days post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start28 Apr 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2031 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barathi Sethuraman, Study director, Abbott Structural Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061004
- Sponsor's protocol ID
- ABT-CIP-10354
- Status last verified
- Dec 2025
- First submitted
- 20 Sep 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cephea Early Feasibility Study
- ClinicalTrials.gov ID
- NCT05061004
- Acronym / sponsor ID
- ABT-CIP-10354
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 29 Sep 2021 (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 study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Cephea Mitral Valve SystemTreatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria.
- LVEF ≥ 30%
- In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.
Key exclusion criteria (2 listed)
- Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
- Need for emergent or urgent surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephea Mitral Valve SystemTranscatheter mitral valve replacement | Device | Treatment |
Primary outcome
Primary Safety Endpoint
Time frame: 30 days post implant
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Primary Effectiveness Endpoint
Time frame: 30 days post implant
Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.
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 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
Active, not recruiting
The ENCIRCLE Trial
Mitral Regurgitation, Mitral Valve Insufficiency
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.
Clinical Project Manager contact
Barathi Sethuraman study director
Abbott Structural Heart
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephea Mitral Valve System in people with Mitral Regurgitation, run by Abbott Medical Devices at 22 sites in 2 countries.
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 3 inclusion and 2 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 11 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 22 sites in United States, Canada. 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 Leslie Centeno (+1 818-294-3041, leslie.centeno@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Endpoint (time frame: 30 days post implant). The study lists 2 primary outcomes in all. 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 11 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.