NCT05061004

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
58mo left

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

22 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Apr 2022Mar 2031

First Submitted

Initial submission to the registry

September 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2021

Completed
7 months until next milestone

Study Start

First participant enrolled

April 28, 2022

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

April 8, 2026

Status Verified

December 1, 2025

Enrollment Period

4.7 years

First QC Date

September 20, 2021

Last Update Submit

April 7, 2026

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • Primary Safety Endpoint

    Freedom from all-cause mortality, which will be assessed at 30 days post implant.

    30 days post implant

  • Primary Effectiveness Endpoint

    Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.

    30 days post implant

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

Cephea Mitral Valve SystemDEVICE

Transcatheter mitral valve replacement

Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Banner-University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

NOT YET RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

University of California - Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Los Robles Regional Medical Center

Thousand Oaks, California, 91360, United States

RECRUITING

Emory University Hospital

Atlanta, Georgia, 30308, United States

RECRUITING

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67214, United States

RECRUITING

University of Michigan - Davis Medical Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

RECRUITING

New York-Presbyterian/Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

RECRUITING

Atrium Health - Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

Allegheny General Hospital - ASRI

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

Ascension Saint Thomas

Nashville, Tennessee, 37205, United States

RECRUITING

Vanderbilt Heart & Vascular Institute

Nashville, Tennessee, 37208, United States

RECRUITING

Houston Methodist

Houston, Texas, 77030, United States

RECRUITING

Sentara Norfolk General Hospital

Norfolk, Virginia, 23507, United States

RECRUITING

Swedish Medical Center

Seattle, Washington, 98122, United States

RECRUITING

Institut de Cardiologie de Montreal

Montreal, Quebec, Canada

COMPLETED

IUCPQ-ULaval

Québec, Quebec, G1V 4G5, Canada

WITHDRAWN

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Barathi Sethuraman

    Abbott Structural Heart

    STUDY DIRECTOR

Central Study Contacts

Leslie Centeno

CONTACT

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

Clinical Project Manager

CONTACT

Cephea_FS@abbott.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

September 29, 2021

Study Start

April 28, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2031

Last Updated

April 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)US(20)