Cephea Early Feasibility Study

Investigator: Sachin Goel, MD

Study Coordinator: Deena Victor

Status: Enrolling

ClinicalTrials.gov Number: NCT05061004

Phone: 713.441.4536

Protocol Number: PRO00033739

Description

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 regurgitation = Grade III in whom transcatheter therapy is deemed more appropriate than open heart surgery. Key Inclusion Criteria: Mitral regurgitation = Grade III 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.
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