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Cephea Early Feasibility Study

StatusRecruiting
PhaseNot applicable
Started2022-04-28
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Study Design, Eligibility, Contacts/Locations v22
Enrollment increased: 50 → 90 participants
Eligibility criteria+63 characters
[...] /or severe mitral valve stenosis (mitral valve area ≤ 1.5cm² and/or mean transmitral gradient ≥10 mmHg at normal heart rate) per American Society of Echocardiography criteria. LVEF ≥ [...]
Study sitescontacts updated at 6 of 22 sites
2026-07-07
Study Status, Contacts/Locations v21
Study sites22 entries, revised
Ascension Via Christi RegionalHospitals Medical Center - St. Francis CampusWichita
2026-04-07
Study Status, Contacts/Locations v20
Study sites22 entries, revised
Institut de Cardiologie de QuebecIUCPQ-ULaval
2026-02-04
Study Status, Contacts/Locations v19
Primary completion date2026-03-01→2026-12-31
Study sites21→22
2025-12-03
Study Status, Oversight, Contacts/Locations v18
Study sitesdetails revised at 1 of 21 sites
Show 17 earlier versions
2025-09-29
Study Status, Contacts/Locations v17
Study sites21 entries, revised
Montefiore Medical Center - Moses Division Atrium Health - Carolinas Medical Center St.Ascension Saint Thomas Hospital TheHouston Methodist Hospital
2025-03-20
Study Status, Oversight, Contacts/Locations v16
Study sites14→21
2024-10-30
Study Status, Study Design v15
Primary completion date2024-06-01→2026-03-01
Completion date2029-06-01→2031-03-01
Enrollment target30→50
2024-01-22
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v14
Eligibility criteria+104 characters
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 ≥ 3 [...]
2023-11-30
Study Status, Contacts/Locations v13
Study sitesdetails revised at 2 of 14 sites
2023-08-25
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 14 sites
2023-08-09
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 14 sites
2023-07-11
Study Status, Contacts/Locations v10
Primary completion date2023-07-01→2024-06-01
Completion date2028-01-01→2029-06-01
Study sitescontacts updated at 1 of 14 sites
2023-04-11
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 14 sites
2023-03-27
Study Status, Contacts/Locations v8
Study sites11→14
2022-08-23
Study Status, Contacts/Locations v7
Study sites10→11
2022-08-16
Withheld→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v6
Trial statusWithheld→Recruiting
Primary completion datenot stated→2023-07-01
Completion datenot stated→2028-01-01
Start datenot stated→2022-04-28
Lead sponsor[Redacted]→Abbott Medical Devices
Study title-35 characters
[TrialCephea ofEarly deviceFeasibility that is not approved or cleared by the U.S. FDA]Study
2022-05-25
5 amendments v1-v5
5 re-verifications since 2022-01-25, no change to tracked fields
2021-09-20
Original filing
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.
Trial Details
NCT Number NCT05061004
Lead Sponsor Abbott Medical Devices
Conditions Mitral Regurgitation
Enrollment 90 participants
Start Date 2022-04-28
Primary Completion 2026-12-31 (estimated)
Study Completion 2031-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-11