To assess the safety and performance of the Cephea Transseptal Mitral Valve System for the treatment of symptomatic moderate to severe degenerative or functional mitral regurgitation, in patients who are poor candidates for surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.
St. Vincent's Hospital
Sydney, New South Wales, Australia
Safety as measured by freedom from major adverse events
Freedom from major adverse events, including: * All-cause mortality * Disabling stroke * Myocardial infarction * Renal failure requiring dialysis * Life-threatening bleeding * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention.
Time frame: 30 days
Performance
Reduction in mitral regurgitation to ≤1+
Time frame: 30 days
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