Cephea Transseptal Mitral Valve System FIH

NCT ID: NCT03988946

Last Updated: 2020-01-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2019-12-31

Brief Summary

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To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.

Detailed Description

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Conditions

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Mitral Regurgitation

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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Transcatheter Mitral Valve Replacement

Replacement valve delivered through a transfemoral access and transseptal approach

Group Type EXPERIMENTAL

Transcatheter Mitral Valve Replacement via Transseptal Access

Intervention Type DEVICE

The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.

Interventions

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Transcatheter Mitral Valve Replacement via Transseptal Access

The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

MVARC
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephea Valve Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Helen J Scotch

Role: STUDY_DIRECTOR

Cephea Valve Technologies

Locations

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St. Vincent's Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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CP21549

Identifier Type: -

Identifier Source: org_study_id

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