Cephea Transseptal Mitral Valve System FIH

Not Applicable

Completed

• Conditions: Mitral Regurgitation
• Interventions: Device: Transcatheter Mitral Valve Replacement via Transseptal Access

• Registration Number: NCT03988946
• Lead Sponsor: Cephea Valve Technologies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-06-14
• Study First Posted: 2019-06-18
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Mitral Valve Replacement	Transcatheter Mitral Valve Replacement via Transseptal Access	Replacement valve delivered through a transfemoral access and transseptal approach

Primary Outcome Measures

Name	Time	Method
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+

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇦🇺 Sydney, New South Wales, Australia