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Cephea Transseptal Mitral Valve System FIH

Primary Purpose

Mitral Regurgitation

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Transcatheter Mitral Valve Replacement via Transseptal Access

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

MVARC

Sites / Locations

St. Vincent's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Mitral Valve Replacement

Arm Description

Replacement valve delivered through a transfemoral access and transseptal approach

Outcomes

Primary Outcome Measures

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.

Performance

Reduction in mitral regurgitation to ≤1+

Secondary Outcome Measures

Full Information

NCT ID

NCT03988946

First Posted

January 10, 2019

Last Updated

January 21, 2020

Sponsor

Cephea Valve Technologies

1. Study Identification

Unique Protocol Identification Number

NCT03988946

Brief Title

Cephea Transseptal Mitral Valve System FIH

Official Title

Cephea Mitral Valve and Transseptal Delivery System FIH

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cephea Valve Technologies

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mitral Regurgitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transcatheter Mitral Valve Replacement

Arm Type

Experimental

Arm Description

Replacement valve delivered through a transfemoral access and transseptal approach

Intervention Type

Device

Intervention Name(s)

Transcatheter Mitral Valve Replacement via Transseptal Access

Intervention Description

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.

Primary Outcome Measure Information:

Title

Safety as measured by freedom from major adverse events

Description

Time Frame

30 days

Title

Performance

Description

Reduction in mitral regurgitation to ≤1+

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

MVARC

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen J Scotch

Organizational Affiliation

Cephea Valve Technologies

Official's Role

Study Director

Facility Information:

Facility Name

St. Vincent's Hospital

City

Sydney

State/Province

New South Wales

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Cephea Transseptal Mitral Valve System FIH

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