Applause Study I - Append System Early Feasibility Study

Recruiting N/A Interventional Study
Non Valvular Atrial Fibrillation
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Append Medical Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 …
Contacts

Liz Zinger, MSc

+972-50-2071741

liz.zinger@appendmedical.com

CONTACT