NCT07278869

Applause Study I - Append System Early Feasibility Study

Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Append Medical Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Valvular Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Left Atrial Appendage Elimination: Append System	Elimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-09-01
• Completion: 2031-12-01
• First posted: 2025-12-12
• Last updated: 2025-12-17

Regulatory

• FDA-regulated device study