Cephea Early Feasibility Study

January 22, 2024 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)

30

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 Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Active, not recruiting
        • Institut de Cardiologie de Quebec
    • Quebec
      • Montreal, Quebec, Canada
        • Active, not recruiting
        • Institut de Cardiologie de Montreal
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Principal Investigator:
          • Raj Makkar
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California - Davis Medical Center
        • Principal Investigator:
          • Jason Rogers
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Contact:
        • Principal Investigator:
          • Vinod Thourani
        • Principal Investigator:
          • Pradeep Yadav
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Cardiovascular Research Institute of Kansas
        • Contact:
        • Principal Investigator:
          • Bassem Chehab
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • Gorav Ailawadi
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute
        • Principal Investigator:
          • Mario Goessl
        • Contact:
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • Mohamed Azeem Latib
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • Samir Kapadia
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • St. Thomas Hospital
        • Principal Investigator:
          • Evelio Rodriguez
        • Contact:
          • Kolie Gasaway
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Withdrawn
        • Sentara Norfolk General Hospital

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)

June 1, 2024

Study Completion (Estimated)

June 1, 2029

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 (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

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

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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