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 — DEVICE
    Elimination 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 System
    Elimination 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

Locations (3)

FacilityCityStateZIPSite coordinators
Arrhythmia Research GroupJonesboroArkansas72401-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

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