Cephea Early Feasibility Study

Conditions

• Mitral Regurgitation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cephea Mitral Valve System — DEVICE
  Transcatheter mitral valve replacement

Study Details

The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.

Key Dates

Start date

Apr 28, 2022

Status verified

Dec 2025

Primary completion

Dec 31, 2026

Completion

Mar 1, 2031

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment
  Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: 30 days post implant ]

Central Contacts

• Leslie Centeno
  +1 818-294-3041
  [email protected]
• Clinical Project Manager
  [email protected]

Locations (20)

Find similar trials in Phoenix, AZ

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