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| Name | Class |
|---|---|
| Servier | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial Fibrillation and/or Atrial Flutter | Subjects taking edoxaban 30mg or 60 mg will be followed for 2 years. Subjects will perform the Montreal Cognitive Assessment (MoCA) Test at baseline and 1-year follow up. They will also answer the Anti-Clot Treatment questionnaire (ACTS-Q) at 1-year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edoxaban Pill | Drug | Subjects will be taking edoxaban 30 or 60 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years | |
| Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS) | 2 years | |
| Cognitive function using the Montreal Cognitive Assessment (MoCA) test | 2 years | |
| Compliance of subjects to edoxaban treatment | 2 years | |
| Reasons for choosing edoxaban and reasons for the dosage | 2 years | |
| Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria) | 2 years | |
| Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE) | 2 years | |
| Bleeding (Frequency, Location, Severity, Type of intervention and Outcome) | 2 years | |
| Death (CV and non-CV) | 2 years | |
| Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patient diagnosed or confirmed with Atrial Fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD) within the last 12 months, according to local standard procedures, judged by the investigator to be at risk of stroke and in whom anticoagulation with a NOAC drugs is clinically indicated and who are prescribed edoxaban.
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| Name | Affiliation | Role |
|---|---|---|
| Katia Dyrda, MD | Montreal Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby | Granby | Quebec | Canada | |||
| CISSS de la Montérégie Centre |
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| Physician satisfaction with regards to edoxaban treatment | 2 years |
| Greenfield Park |
| Quebec |
| Canada |
| CISSS de Laval | Laval | Quebec | Canada |
| Montreal Heart Institute | Montreal | Quebec | H1T 1C8 | 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 | G5Y 4T8 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke | Sherbrooke | Quebec | Canada |
| CIUSSS de la Mauricie-et-du-Centre-du-Québec | Trois-Rivières | Quebec | Canada |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C552171 | edoxaban |
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