Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF

NANot yet recruitingINTERVENTIONAL
Enrollment

2,931

Participants

Timeline

Start Date

December 1, 2025

Primary Completion Date

December 1, 2029

Study Completion Date

December 1, 2034

Conditions
Atrial FibrillationLeft Atrial Appendage ThrombosisCVA
Interventions
DEVICE

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.

DRUG

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.

Trial Locations (1)

48202

Henry Ford Hospital, Detroit

All Listed Sponsors
collaborator

Lifetech Scientific (Shenzhen) Co., Ltd.

INDUSTRY

lead

Brian O'Neill MD

OTHER

NCT04684212 - Can the Lambre Device Occlude IRRegular And Large Appendages in Patients With Non-Valvular AF | Biotech Hunter | Biotech Hunter