Cephea South America Feasibility Study

NCT ID: NCT07244939

Last Updated: 2026-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-17

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mitral Regurgitation Mitral Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cephea TMVR

Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

Group Type EXPERIMENTAL

Cephea Mitral Valve System

Intervention Type DEVICE

Cephea Mitral Valve System

Interventions

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Cephea Mitral Valve System

Cephea Mitral Valve System

Intervention Type DEVICE

Eligibility Criteria

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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

Exclusion Criteria

* Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function
* Need for emergent or urgent surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barathi Sethuraman

Role: STUDY_DIRECTOR

Abbott Structural Heart

Locations

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Instituto do Coracao (InCor) - HCFMUSP

São Paulo, , Brazil

Site Status RECRUITING

Instituto Nacional del Torax

Santiago, , Chile

Site Status RECRUITING

Hospital Clinico San Borja Arriarán

Santiago, , Chile

Site Status RECRUITING

Countries

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Brazil Chile

Central Contacts

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Leslie Centeno

Role: CONTACT

+1 818-294-3041

Clinical Project Manager

Role: CONTACT

Facility Contacts

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Joao Mourao

Role: primary

Patricia Sandoval

Role: primary

Maria Jesus Vergara

Role: primary

Other Identifiers

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ABT-CIP-10554

Identifier Type: -

Identifier Source: org_study_id

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