Applause Study I - Append System Early Feasibility Study
ConditionNon Valvular Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAppend Medical Ltd.
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.
Eligibility criteria
Qualifiers
Male or non-pregnant female aged ≥18 years
Documented non-valvular AF (paroxysmal, persistent, permanent or non-rheumatic valve-related AF)
The subject has a calculated CHA2DS2-VASc score of 2 or greater for males or 3 or greater for females.
The subject is eligible for the defined protocol medication regimen of anticoagulation and antiplatelet therapy following Append procedure.
Disqualifiers
Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
Atrial fibrillation that is defined by a single occurrence or that is considered to be reversible (e.g., due to thyroid disorders, acute alcohol intoxication, trauma, or recent major surgical procedures).
Patients with an indication for chronic oral anticoagulation other than AF (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve)
Clinically significant Severe heart failure (New York Heart Association functional class IV)
Trial design
Treatments tested in this trial
- Left Atrial Appendage Elimination: Append System
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov