Recruiting

CepheaCephea Early Feasibility Study

Sponsor:

Abbott Medical Devices

Code:

NCT05061004

Conditions

Mitral Regurgitation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cephea Mitral Valve System

Study Details

Brief 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 appropriate than open heart surgery.

Conditions

Mitral Regurgitation

Study ID

NCT05061004

Start date

Apr 28, 2022

Status verified date

Dec, 2025

Completion date

Mar 1, 2031

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) 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:

Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
Need for emergent or urgent surgery.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

Interventions

Cephea Mitral Valve System

Transcatheter mitral valve replacement

Primary outcome measure

Primary Safety Endpoint [ Time Frame: 30 days post implant ]
Primary Effectiveness Endpoint [ Time Frame: 30 days post implant ]

Central Contacts and Locations

Central contacts

Leslie Centeno

+1 818-294-3041 leslie.centeno@abbott.com

Clinical Project Manager

Cephea_FS@abbott.com

Locations

Banner-University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Paul Sorajja, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Andjela Kremenovic

417-353-7177 Andjela.Kremenovic@cshs.org

Principal Investigator:

Raj Makkar, MD

University of California - Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Heather Houston

916-734-5155 hhouston@ucdavis.edu

Principal Investigator:

Jason Rogers, MD

Los Robles Regional Medical Center

Recruiting

Thousand Oaks, California, United States, 91360

Contacts

Mane Arabyan

805-796-3746 Mane.arabyan@hcahealthcare.com

Principal Investigator:

Saibal Kar, MD

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Elizabeth Charles

404-686-1249 elizabeth.z.charles@emory.edu

Principal Investigator:

Adam Greenbaum, MD

Piedmont Heart Institute

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Danielle Griffith

404-605-2958 Danielle.griffith@piedmont.org

Principal Investigator:

Vinod Thourani, MD

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Maggie McNamara

312-926-0846 margaret.mcnamara@nm.org

Principal Investigator:

Anita Asgar, MD

Ascension Via Christi Hospitals Wichita

Recruiting

Wichita, Kansas, United States, 67214

Contacts

Lindsey Steele

316-268-8092 lindsey.steele@ascension.org

Principal Investigator:

Bassem Chehab, MD

University of Michigan - Davis Medical Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Allison Schley

734-232-4319 schleya@med.umich.edu

Principal Investigator:

Gorav Ailawadi, MD

Minneapolis Heart Institute

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jennifer Nguyen

612-863-9291 Jennifer.nguyen@allina.com

Principal Investigator:

Mario Goessl, MD

New York-Presbyterian/Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Kate Dalton

212-342-1820 keb2114@columbia.edu

Principal Investigator:

Torsten Vahl

Montefiore Medical Center - Moses Campus

Recruiting

The Bronx, New York, United States, 10467

Contacts

Tammy Rodriguez Guzman

718-920-6523 tamrodrigu@montefiore.org

Principal Investigator:

Mohamed Azeem Latib, MD

Atrium Health - Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Montana Bright

montana.bright@atriumhealth.org

Principal Investigator:

Michael Rinaldi, MD

The Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Emily Tylicki

216-444-6950 tylicke@ccf.org

Principal Investigator:

Samir Kapadia, MD

Allegheny General Hospital - ASRI

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Tracy Spirk

412-359-4025 tracy.spirk@ahn.org

Principal Investigator:

Walter McGregor, MD

Ascension Saint Thomas

Recruiting

Nashville, Tennessee, United States, 37205

Contacts

Kolie Gasaway

615-222-3227 kolie.gasaway@ascension.org

Principal Investigator:

Evelio Rodriguez, MD

Vanderbilt Heart & Vascular Institute

Recruiting

Nashville, Tennessee, United States, 37208

Contacts

Kathryn Adams

kathy.adams@vumc.org

Principal Investigator:

Kashish Goel

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Deena Victor

dcvictor@HoustonMethodist.org

Principal Investigator:

Sachin Goel, MD

Sentara Norfolk General Hospital

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Christine Calayo

757-388-3876 cacalayo@sentara.com

Principal Investigator:

Matthew Summers, MD

Swedish Medical Center

Recruiting

Seattle, Washington, United States, 98122

Contacts

Jennifer Nagel

jennifer.nagel@swedish.org

Principal Investigator:

Sameer Gafoor, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jul 8, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-07-08.