A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation

Conditions studied

Cardiovascular Diseases, Mitral Regurgitation Functional, Mitral Valve Disease

What is being tested

• DEVICE: Millipede Transcatheter Annuloplasty Ring System (Millipede System)

What it measures

• Primary Safety Endpoint, The composite (aggregate) of the following implant-related and/or delivery-related serious adverse events (SAEs) at 30 days post index procedure (based on MVARC definitions and adjudicated by an independent clinical events committee). The unit of outcome measure is % (n/N): * Mortality: all-cause * Stroke: disabling and non-disabling; Bleeding: life-threatening based MVARC scale * Major access site vascular complications * Major cardiac structural complications due to access-related issues * Acute kidney injury (AKI; ≤7 days post index procedure): based on the Acute Kidney Injury Network (AKIN) --System Stage 3 (including renal replacement therapy) or Stage 2 * Myocardial infarction (MI; periprocedural \[≤48 hours\] or spontaneous \[\>48 hours\]) * Coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft * Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or repeat intervention, 30 days post index procedure
• Primary Technical Success Endpoint, Technical Success (measured at exit from the catheterization laboratory) is defined per Mitral Valve Academic Research Consortium (MVARC ). All of the following must be present: Absence of procedural mortality; and Successful access, delivery and retrieval of the device delivery system; and Successful deployment and correct positioning of the first intended device; and Freedom from emergency surgery or reintervention related to the device or access procedure., Index procedure exit from the catheterization laboratory