The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.
This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's discretion. Registry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic Case Report Form (eCRF). Data available in the patient's file will be collected. The only procedure to be performed in the context of this registry is the completion of questionnaires: the Montreal Cognitive Assessment (MoCA©) test and the Anti-Clot-Treatment Scale (ACTS-Q) questionnaire.
Study Type
OBSERVATIONAL
Enrollment
136
Subjects will be taking edoxaban 30 or 60 mg
CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby
Granby, Quebec, Canada
CISSS de la Montérégie Centre
Greenfield Park, Quebec, Canada
CISSS de Laval
Laval, Quebec, Canada
Montreal Heart Institute
Characterization of patients with diagnosed or confirmed atrial fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD), within the last 12 months
Time frame: 2 years
Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
Time frame: 2 years
Cognitive function using the Montreal Cognitive Assessment (MoCA) test
Time frame: 2 years
Compliance of subjects to edoxaban treatment
Time frame: 2 years
Reasons for choosing edoxaban and reasons for the dosage
Time frame: 2 years
Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
Time frame: 2 years
Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
Time frame: 2 years
Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
Time frame: 2 years
Death (CV and non-CV)
Time frame: 2 years
Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
Time frame: 2 years
Physician satisfaction with regards to edoxaban treatment
Time frame: 2 years
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Montreal, Quebec, Canada
IUCPQ
Québec, Quebec, Canada
CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski
Rimouski, Quebec, Canada
CISSS de Chaudière-Appalaches - Hopital Saint-Georges
Saint-Georges, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
CIUSSS de la Mauricie-et-du-Centre-du-Québec
Trois-Rivières, Quebec, Canada