Applause Study I - Append System Early Feasibility Study
Part of paid clinical trials in Jonesboro, Arkansas.
- Sponsor
- Append Medical Ltd.
- Study ID
- NCT07278869
- Status
- Recruiting
Conditions
- Non Valvular Atrial Fibrillation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Left Atrial Appendage Elimination: Append System — DEVICEElimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.
Study Details
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.
Key Dates
- Start date
- Apr 29, 2026
- Status verified
- May 2026
- Primary completion
- Sep 30, 2027
- Completion
- Mar 31, 2033
Study Design
- Enrollment
- 15 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Append SystemElimination of the left atrial appendage (LAA) using the Append System through a transcatheter procedure that invaginates and ligates the LAA tissue.
Primary Outcome Measure
Composite major adverse events [ Time Frame: 30 days ]
Central Contacts
- Liz Zinger, MSc+972-50-2071741
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | - |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | - |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | - |