A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.

Conditions studied

Mitral Regurgitation

What is being tested

• DEVICE: GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System

What it measures

• Effectiveness: Acute procedural success (APS), APS is defined as the successful implantation of the GeminiOne device and achieving residual MR of 2+ or less at discharge. lf the discharge echocardiogram is unavailable or difficult to interpret, an echocardiogram taken at 30 days can be used instead. A death before discharge or a reoperation of the mitral valve within 30 days is considered an acute procedural failure., 30 days
• Safety: Absence of device or procedure related major adverse events at 30 days, MAE is defined as the occurrence of any of the following within 30 days: death, myocardial infarction (Ml) stroke, MVARC-defined Grade 3 Acute Kidney Injury (AKl), major access site and vascular complications, major cardiac structural complications or cardiac surgery due to GeminiOne device failure., 30 days