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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT03488420
Study type Observational [Patient Registry]
Source Montreal Heart Institute
Contact
Status Active, not recruiting
Phase
Start date April 30, 2019
Completion date January 31, 2025

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