Cephea South America Feasibility Study

Abbott

Status: Enrolling

Conditions: Mitral Regurgitation; Mitral Stenosis

Treatments: Device: Cephea Mitral Valve System

Study type: Interventional

Funder types: Industry

Identifiers

NCT07244939

ABT-CIP-10554

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: 20 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)

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20 participants in 1 patient group

Cephea TMVR

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