Cephea Early Feasibility Study

April 7, 2026 updated by: Abbott Medical Devices
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Completed
        • Institut de Cardiologie de Montreal
      • Québec, Quebec, Canada, G1V 4G5
        • Withdrawn
        • IUCPQ-Ulaval
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Not yet recruiting
        • Banner-University Medical Center Phoenix
        • Principal Investigator:
          • Paul Sorajja, MD
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar, MD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California - Davis Medical Center
        • Contact:
        • Principal Investigator:
          • Jason Rogers, MD
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Los Robles Regional Medical Center
        • Principal Investigator:
          • Saibal Kar, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • Principal Investigator:
          • Pradeep Yadav, MD
        • Principal Investigator:
          • Vinod Thourani, MD
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • Adam Greenbaum, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
        • Principal Investigator:
          • Anita Asgar, MD
        • Contact:
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Via Christi Regional Medical Center - St. Francis Campus
        • Principal Investigator:
          • Bassem Chehab, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan - Davis Medical Center
        • Principal Investigator:
          • Gorav Ailawadi, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Contact:
        • Principal Investigator:
          • Mario Goessl, MD
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • New York-Presbyterian/Columbia University Medical Center
        • Contact:
        • Principal Investigator:
          • Torsten Vahl
      • The Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Campus
        • Principal Investigator:
          • Mohamed Azeem Latib, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health - Carolinas Medical Center
        • Principal Investigator:
          • Michael Rinaldi, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Samir Kapadia, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital - ASRI
        • Principal Investigator:
          • Walter McGregor, MD
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Ascension Saint Thomas
        • Principal Investigator:
          • Evelio Rodriguez, MD
        • Contact:
      • Nashville, Tennessee, United States, 37208
        • Recruiting
        • Vanderbilt Heart & Vascular Institute
        • Principal Investigator:
          • Kashish Goel
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Sentara Norfolk General Hospital
        • Principal Investigator:
          • Matthew Summers, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Sameer Gafoor, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Device: Cephea Mitral Valve System
Transcatheter mitral valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint
Time Frame: 30 days post implant
Freedom from all-cause mortality, which will be assessed at 30 days post implant.
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.
30 days post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: Barathi Sethuraman, Abbott Structural Heart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

September 20, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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