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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    200
  • sponsor
    Montreal Heart Institute
Updated on 21 March 2022
stenosis
stroke
fibrillation
edoxaban
atrial flutter
anticoagulation therapy

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.

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.

Details
Condition Atrial Fibrillation and Flutter, Valvular Heart Disease
Treatment Edoxaban Pill
Clinical Study IdentifierNCT03488420
SponsorMontreal Heart Institute
Last Modified on21 March 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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