Append Prague Study
ConditionNon Valvular Atrial Fibrillation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAppend Medical Ltd.
About this trial
This study is intended to evaluate the safety and feasibility of the Append System for left atrial appendage (LAA) elimination using a transcatheter procedure that invaginates and ligates the LAA tissue.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Append System
DeviceElimination of the left atrial appendage using the Append System through a transcatheter procedure involving invagination and ligation of the LAA tissue.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Append SystemExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Composite major adverse events
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, and cardiac tamponade or pericardial effusion requiring drainage
Time frame
30 daysSecondary outcomes
1
Composite major adverse events
Composite rate of major adverse events related to the device or procedure, including all-cause mortality, ischemic stroke, systemic embolism, pericardial effusion requiring drainage, major bleeding (BARC 3/ BARC 5), hemorrhagic stroke, and device or procedure-related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, AV fistula repair, or other major endovascular repair
Time frame
6 monthsOther outcomes
1
Procedure and Technical Success
LAA cavity elimination by LAA invagination and ligation with invagination proximal to the LAA ostium and lack of fluid communication between the LA and LAA- observed by TEE
Time frame
30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov