Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)

Conditions
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Atrial Fibrillation and Flutter, Valvular Heart Disease

Intervention / Treatment
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* Drug: Edoxaban Pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged ≥ 18 years at baseline (signing of consent); Willing and able to provide written informed consent; Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form; Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months; Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban. Exclusion Criteria: Patients with AF and/or AFL secondary to reversible cause; Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis; Patients planned to have an intervention for valvular heart disease in the next 12 months; Pregnant or breastfeeding women. Short term anticoagulation post cardioversion or ablation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Atrial Fibrillation and/or Atrial Flutter<br>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. | Drug: Edoxaban Pill<br>* Subjects will be taking edoxaban 30 or 60 mg<br>* Other names: edoxaban tosylate monhydrate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 
| Physician satisfaction with regards to edoxaban treatment |  | 2 years |