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Cephea Transseptal Mitral Valve System FIH

NCT03988946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-01-23

No results posted yet for this study

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.

Conditions

  • Mitral Regurgitation

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Cephea Valve Technologies

    lead INDUSTRY

Principal Investigators

  • Helen J Scotch · Cephea Valve Technologies

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-01
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03988946 on ClinicalTrials.gov