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Completed

NCT Number: NCT03488420

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

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.

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Key information

Conditions

Atrial Fibrillation and Flutter Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Valvular Heart Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby, Granby, Quebec, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Edoxaban Pill

Drug

Subjects will be taking edoxaban 30 or 60 mg

Other names: Lixiana, edoxaban tosylate monhydrate

Primary outcomes

  1. 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

  2. Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)

    Time frame: 2 years

  3. Cognitive function using the Montreal Cognitive Assessment (MoCA) test

    Time frame: 2 years

  4. Compliance of subjects to edoxaban treatment

    Time frame: 2 years

  5. Reasons for choosing edoxaban and reasons for the dosage

    Time frame: 2 years

  6. Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)

    Time frame: 2 years

  7. Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)

    Time frame: 2 years

  8. Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)

    Time frame: 2 years

  9. Death (CV and non-CV)

    Time frame: 2 years

  10. Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban

    Time frame: 2 years

  11. Physician satisfaction with regards to edoxaban treatment

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Collaborators

  • Servier

Registry information

Official study title

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

Acronym: CAPTURE

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 5, 2018
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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