Cephea Early Feasibility Study

Abbott Medical Devices90 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

Interventions

Cephea Mitral Valve SystemDEVICE

Transcatheter mitral valve replacement

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 and/or mean transmitral gradient ≥10 mmHg at normal heart rate) 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 (22)

Banner-University Medical Center Phoenix

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Primary Safety Endpoint

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

Time frame: 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.

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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