AntiPlatelet theraPy stratEgy followiNg Left Atrial appenDAGe closurE
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
The APPENDAGE study is a phase 4 multicentre randomized opened clinical trial comparing 2 different antithrombotic strategies following left atrial appendage closure (LAAC) in patients with non valvular atrial fibrillation (AF). The primary objective of the study is to evaluate the efficacy of Aspirin versus Aspirin + Clopidogrel after LAAC by comparing the occurrence of ischemic lesions on cerebrovascular magnetic resonance imaging (MRI) studies.
Eligibility criteria
Qualifiers
Male or female patients with LAAC indication according to "Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé" (CNEDiMTS) (National Commission for the Evaluation of Medical Devices and Health Technologies) guidelines
Age ≥ 18 years
Written informed consent provided by the patient
Heart team approval: multidisciplinary team including interventional cardiologists, neurologists and other physicians discussing the definitive contraindication for anticoagulation
Disqualifiers
Minors
Unacceptable bleeding risk with double antiplatelet therapy decided by the physician who contraindicated oral anticoagulation
LAAC contraindication : left appendage thrombus
Major disease resulting in a life expectancy of < 1 year
Trial design
Treatments tested in this trial
- Double antiplatelet therapy
- Aspirin
- Brain MRI
- Neurological tests
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov