Early Feasibility Study of the Append System for Left Atrial Appendage (LAA) Elimination by Invagination and Ligation
Append Medical Ltd.
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.
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 i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or non-pregnant female aged ≥18 years 2. Documented non-valvular AF (paroxysmal, persistent, permanent or non-rheumatic valve-related AF) 3. The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females. 4. The subject is eligible for the defined protocol medication regimen of anticoagulation and antiplatelet therapy following Append procedure. 5. The patient is deemed appropriate for LAA ligation by the screening committee and the investigator. 6. The patient has been informed of the nature of the study, agrees to its provis…
Interventions
- DeviceLeft 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.
Location
- Icahn School of Medicine at Mount SinaiNew York, New York