2,931
Participants
Start Date
December 1, 2025
Primary Completion Date
December 1, 2029
Study Completion Date
December 1, 2034
LAmbre PlusTM Left Atrial Appendage Closure System
The LAmbre Plus device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation.
Market approved oral anticoagulation (OAC), such as warfarin (Coumadin), dabigatran (Pradaxa), rivaroxaban (Xarelto), apixiban (Eliquis), edoxaban (Savaysa), or betrixaban (Bevyxxa)
Continuation of market approved OAC drug.
Henry Ford Hospital, Detroit
Lifetech Scientific (Shenzhen) Co., Ltd.
INDUSTRY
Brian O'Neill MD
OTHER