Cephea Early Feasibility Study

Not Applicable

Recruiting

• Conditions: Mitral Regurgitation

• Registration Number: NCT05061004
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-20
• Study First Submitted QC: 2021-09-20
• Study First Posted: 2021-09-29
• Study Start: 2022-04-28
• Status Verified: 2024-10
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-03-01
• Study Completion: 2031-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	30 days post implant	Freedom from all-cause mortality, which will be assessed at 30 days post implant.
Primary Effectiveness Endpoint	30 days post implant	Proportion of subjects with reduction of MR to ≤ Grade I, will be assessed at 30 days post implant.

Trial Locations

Locations (21)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

University of California - Davis Medical Center; 🇺🇸 Sacramento, California, United States

Los Robles Regional Medical Center; 🇺🇸 Thousand Oaks, California, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Piedmont Heart Institute; 🇺🇸 Atlanta, Georgia, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Via Christi Regional Medical Center - St. Francis Campus; 🇺🇸 Wichita, Kansas, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Minneapolis Heart Institute; 🇺🇸 Minneapolis, Minnesota, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

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