Applause Study I - Append System Early Feasibility Study
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.
| Condition(s) | Non Valvular Atrial Fibrillation |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 provisions \& follow-up evaluations, and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC). General Exclusion Criteria: 1. Pregnant o |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Append Medical Ltd. |
| Locations | Jonesboro, Arkansas, United States; Los Angeles, California, United States; New York, New York, United States |
| Start date | 2026-04-29 |
| NCT ID | NCT07278869 |
| Official listing | https://clinicaltrials.gov/study/NCT07278869 |