Cephea Transseptal Mitral Valve System FIH

Cephea Valve Technologies

Status: Completed

Conditions: Mitral Regurgitation

Treatments: Device: Transcatheter Mitral Valve Replacement via Transseptal Access

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988946

CP21549

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

MVARC

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Transcatheter Mitral Valve Replacement

Experimental group

Description:

Replacement valve delivered through a transfemoral access and transseptal approach

Treatment:

Device: Transcatheter Mitral Valve Replacement via Transseptal Access