Recruiting

Cephea Early Feasibility Study

Abbott Medical Devices · NCT05061004

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 90
US sites recruiting: 20
Study start: April 28, 2022
Record last updated: September 11, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Cephea Mitral Valve System

Conditions: Mitral Regurgitation

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

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

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

Recruiting US locations

Banner-University Medical Center Phoenix
Phoenix, AZ 85006
Site contact: Paul Sorajja, MD
Cedars-Sinai Medical Center
Los Angeles, CA 90048
Site contact: Andjela Kremenovic · 417-353-7177 · Andjela.Kremenovic@cshs.org
University of California - Davis Medical Center
Sacramento, CA 95817
Site contact: Heather Houston · 916-734-5155 · hhouston@ucdavis.edu
Los Robles Regional Medical Center
Thousand Oaks, CA 91360
Site contact: Mane Arabyan · (805) 796-3746 · Mane.arabyan@hcahealthcare.com
Emory University Hospital
Atlanta, GA 30308
Site contact: Elizabeth Charles · (404) 686-1249 · elizabeth.z.charles@emory.edu
Piedmont Heart Institute
Atlanta, GA 30309
Site contact: Danielle Griffith · 404-605-2958 · Danielle.griffith@piedmont.org
Northwestern Memorial Hospital
Chicago, IL 60611
Site contact: Maggie McNamara · 312-926-0846 · margaret.mcnamara@nm.org
Ascension Via Christi Hospitals Wichita
Wichita, KS 67214
Site contact: Lindsey Steele · 316-268-8092 · lindsey.steele@ascension.org
University of Michigan - Davis Medical Center
Ann Arbor, MI 48109
Site contact: Allison Schley · 734-232-4319 · schleya@med.umich.edu
Minneapolis Heart Institute
Minneapolis, MN 55407
Site contact: Jennifer Nguyen · 612-863-9291 · Jennifer.nguyen@allina.com
New York-Presbyterian/Columbia University Medical Center
New York, NY 10032
Site contact: Kate Dalton · 212-342-1820 · keb2114@columbia.edu
Montefiore Medical Center - Moses Campus
The Bronx, NY 10467
Site contact: Tammy Rodriguez Guzman · (718) 920-6523 · tamrodrigu@montefiore.org
Atrium Health - Carolinas Medical Center
Charlotte, NC 28203
Site contact: Montana Bright · montana.bright@atriumhealth.org
The Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Emily Tylicki · 216-444-6950 · tylicke@ccf.org
Allegheny General Hospital - ASRI
Pittsburgh, PA 15212
Site contact: Tracy Spirk · (412) 359-4025 · tracy.spirk@ahn.org
Ascension Saint Thomas
Nashville, TN 37205
Site contact: Kolie Gasaway · (615) 222-3227 · kolie.gasaway@ascension.org
Vanderbilt Heart & Vascular Institute
Nashville, TN 37208
Site contact: Kathryn Adams · kathy.adams@vumc.org
Houston Methodist
Houston, TX 77030
Site contact: Deena Victor · dcvictor@HoustonMethodist.org
Sentara Norfolk General Hospital
Norfolk, VA 23507
Site contact: Christine Calayo · (757) 388-3876 · cacalayo@sentara.com
Swedish Medical Center
Seattle, WA 98122
Site contact: Jennifer Nagel · jennifer.nagel@swedish.org

Study contacts (from the official record)

Leslie Centeno · +1 818-294-3041 · leslie.centeno@abbott.com
Clinical Project Manager · Cephea_FS@abbott.com