NCT07244939

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
28mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
2 countries

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jun 2025Sep 2028

Study Start

First participant enrolled

June 17, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

February 6, 2026

Status Verified

November 1, 2025

Enrollment Period

1.2 years

First QC Date

November 14, 2025

Last Update Submit

February 5, 2026

Conditions

Mitral RegurgitationMitral Stenosis

Keywords

Symptomatic mitral valve diseaseCephea Mitral Valve System

Outcome Measures

Primary Outcomes (2)

  • Freedom from all-cause mortality

    Primary Safety Endpoint

    30 days post implant

  • Reduction of MR to ≤ Grade I

    Primary Effectiveness Endpoint

    30 days post implant

Study Arms (1)

Cephea TMVR

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

Cephea Mitral Valve System

Cephea TMVR

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 (3)

Instituto do Coracao (InCor) - HCFMUSP

São Paulo, 05403-900, Brazil

RECRUITING

Instituto Nacional del Torax

Santiago, 8320000, Chile

RECRUITING

Hospital Clinico San Borja Arriarán

Santiago, 8360160, Chile

RECRUITING

MeSH Terms

Conditions

Mitral Valve InsufficiencyMitral Valve Stenosis

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

November 14, 2025

First Posted

November 24, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

February 6, 2026

Record last verified: 2025-11

Locations

BR(1)CL(2)