Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-03 @ 10:41 AM
Study NCT ID:
NCT07278869
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applause Study I - Append System Early Feasibility Study
Sponsor:
Append Medical Ltd.
Organization:
Study Overview
Official Title:
Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Applause
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: