Cephea South America Feasibility Study

Abbott Medical Devices20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mitral Regurgitation Mitral Stenosis

Interventions

Cephea Mitral Valve SystemDEVICE

Cephea Mitral Valve System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Instituto do Coracao (InCor) - HCFMUSP

São Paulo, Brazil

RECRUITING

Instituto Nacional del Torax

Santiago, Chile

RECRUITING

Hospital Clinico San Borja Arriarán

Santiago, Chile

RECRUITING

Outcomes

Primary Outcomes

Freedom from all-cause mortality

Primary Safety Endpoint

Time frame: 30 days post implant

Reduction of MR to ≤ Grade I

Primary Effectiveness Endpoint

Time frame: 30 days post implant

Central Contacts

Leslie Centeno

CONTACT

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

Clinical Project Manager

CONTACT

Cephea_FS@abbott.com

Data from ClinicalTrials.gov

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