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Cephea Early Feasibility Study

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Abbott

Status

Enrolling

Conditions

Mitral Regurgitation

Treatments

Device: Cephea Mitral Valve System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05061004
ABT-CIP-10354

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  • Mitral valve disease resulting in mitral regurgitation (MR ≥ Grade III) and/or severe mitral valve stenosis (mitral valve area ≤ 1.5cm²) per American Society of Echocardiography criteria.
  • LVEF ≥ 30%
  • In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery.

Key Exclusion Criteria:

  • Prior surgical or interventional treatment that interferes with the Cephea valve delivery or function.
  • Need for emergent or urgent surgery.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

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

Trial contacts and locations

14

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Central trial contact

Shimako Nakajima

Data sourced from clinicaltrials.gov

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