Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05061004

Cephea Early Feasibility Study

Led by Abbott Medical Devices · Updated on 2026-04-08

50

Participants Needed

22

Research Sites

461 weeks

Total Duration

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AI-Summary

What this Trial 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.

CONDITIONS

Official Title

Cephea Early Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Mitral valve disease causing mitral regurgitation Grade III or higher and/or severe mitral valve stenosis with valve area 1.5 cm² or less according to American Society of Echocardiography criteria
  • Left ventricular ejection fraction (LVEF) of 30% or greater
  • Transcatheter therapy judged by the Site Heart Team to be more appropriate than open heart surgery
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 22 locations

1

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States, 85006

Not Yet Recruiting

2

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

3

University of California - Davis Medical Center

Sacramento, California, United States, 95817

Actively Recruiting

4

Los Robles Regional Medical Center

Thousand Oaks, California, United States, 91360

Actively Recruiting

5

Emory University Hospital

Atlanta, Georgia, United States, 30308

Actively Recruiting

6

Piedmont Heart Institute

Atlanta, Georgia, United States, 30309

Actively Recruiting

7

Northwestern Memorial Hospital

Chicago, Illinois, United States, 60611

Actively Recruiting

8

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States, 67214

Actively Recruiting

9

University of Michigan - Davis Medical Center

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

10

Minneapolis Heart Institute

Minneapolis, Minnesota, United States, 55407

Actively Recruiting

11

New York-Presbyterian/Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

12

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States, 10467

Actively Recruiting

13

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Actively Recruiting

14

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

15

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, United States, 15212

Actively Recruiting

16

Ascension Saint Thomas

Nashville, Tennessee, United States, 37205

Actively Recruiting

17

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, United States, 37208

Actively Recruiting

18

Houston Methodist

Houston, Texas, United States, 77030

Actively Recruiting

19

Sentara Norfolk General Hospital

Norfolk, Virginia, United States, 23507

Actively Recruiting

20

Swedish Medical Center

Seattle, Washington, United States, 98122

Actively Recruiting

21

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

Completed

22

IUCPQ-ULaval

Québec, Quebec, Canada, G1V 4G5

Withdrawn

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Research Team

L

Leslie Centeno

CONTACT

C

Clinical Project Manager

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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