This early feasibility study is intended to evaluate the safety and feasibility of the Append System for eliminating the left atrial appendage (LAA) through a transcatheter procedure that invaginates and ligates the LAA tissue.
The objective of this study is to evaluate the safety and performance of the Append System in patients with non-valvular atrial fibrillation who are considered appropriate candidates for LAA closure to reduce the risk of thromboembolism originating from the LAA. The Append System is designed to eliminate the LAA without the use of a permanent metallic implant. The procedure is performed via a transfemoral, transseptal, transcatheter approach. During the procedure, the LAA is invaginated into the left atrium (LA), and the inverted tissue is ligated using a standard surgical suture, resulting in elimination of the LAA cavity. Patients will be followed for up to 5 years after the procedure to assess safety, device performance, and long-term outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Elimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.
Composite major adverse events
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, and cardiac tamponade or pericardial effusion requiring drainage
Time frame: 30 days
Composite major adverse events
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, pericardial effusion requiring drainage, major bleeding (BARC 3/ BARC 5), hemorrhagic stroke, and device or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair
Time frame: 6 months
Procedure and Technical Success
LAA cavity elimination by LAA invagination and ligation with invagination proximal to the LAA ostium and lack of fluid communication between the LA and LAA- observed by TEE
Time frame: 30 days
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