Cephea Transseptal Mitral Valve System FIH

Cephea Mitral Valve and Transseptal Delivery System FIH

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03988946

Enrollment

Registered

2019-06-18

Start date

2018-08-01

Completion date

2019-12-31

Last updated

2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Brief summary

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.

Interventions

DEVICETranscatheter 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

MVARC

Design outcomes

Primary

Measure	Time frame	Description
Safety as measured by freedom from major adverse events	30 days	Freedom from major adverse events, including: * All-cause mortality * Disabling stroke * Myocardial infarction * Renal failure requiring dialysis * Life-threatening bleeding * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Performance	30 days	Reduction in mitral regurgitation to ≤1+

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026