Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2025-06-17
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cephea TMVR
Treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) with the Cephea Mitral Valve System
Cephea Mitral Valve System
Cephea Mitral Valve System
Interventions
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Cephea Mitral Valve System
Cephea Mitral Valve System
Eligibility Criteria
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Inclusion Criteria
* LVEF ≥ 30%
* In the judgement of the Site Heart Team, transcatheter therapy is deemed more appropriate than open heart surgery
Exclusion Criteria
* Need for emergent or urgent surgery
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Barathi Sethuraman
Role: STUDY_DIRECTOR
Abbott Structural Heart
Locations
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Instituto do Coracao (InCor) - HCFMUSP
São Paulo, , Brazil
Instituto Nacional del Torax
Santiago, , Chile
Hospital Clinico San Borja Arriarán
Santiago, , Chile
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABT-CIP-10554
Identifier Type: -
Identifier Source: org_study_id
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