NCT03988946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

1.4 years

First QC Date

January 10, 2019

Last Update Submit

January 21, 2020

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

  • Safety as measured by freedom from major adverse events

    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.

    30 days

  • Performance

    Reduction in mitral regurgitation to ≤1+

    30 days

Study Arms (1)

Transcatheter Mitral Valve Replacement

EXPERIMENTAL

Replacement valve delivered through a transfemoral access and transseptal approach

Device: Transcatheter Mitral Valve Replacement via Transseptal Access

Interventions

Transcatheter Mitral Valve Replacement via Transseptal AccessDEVICE

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.

Transcatheter Mitral Valve Replacement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
MVARC

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital

Sydney, New South Wales, Australia

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Helen J Scotch

    Cephea Valve Technologies

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2019

First Posted

June 18, 2019

Study Start

August 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

January 23, 2020

Record last verified: 2020-01

Locations

AU(1)