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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Valvular Heart Disease; Atrial Fibrillation and Flutter
• Intervention / Treatment: Drug: Edoxaban Pill

Detailed 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 Type: Observational
• Enrollment (Actual): 133

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Granby, Quebec, Canada
      • CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby
    • Greenfield Park, Quebec, Canada
      • CISSS de la Montérégie Centre
    • Laval, Quebec, Canada
      • CISSS de Laval
    • Montréal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute
    • Québec, Quebec, Canada
      • IUCPQ
    • Rimouski, Quebec, Canada
      • CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski
    • Saint-Georges, Quebec, Canada, G5Y 4T8
      • CISSS de Chaudière-Appalaches - Hopital Saint-Georges
    • Sherbrooke, Quebec, Canada
      • Centre Hospitalier Universitaire de Sherbrooke
    • Trois-Rivières, Quebec, Canada
      • CIUSSS de la Mauricie-et-du-Centre-du-Quebec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Male and female patients aged ≥ 18 years at baseline (signing of consent);
2. Willing and able to provide written informed consent;
3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;
4. 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;
5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.

Exclusion Criteria:

1. Patients with AF and/or AFL secondary to reversible cause;
2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;
3. Patients planned to have an intervention for valvular heart disease in the next 12 months;
4. Pregnant or breastfeeding women.
5. Short term anticoagulation post cardioversion or ablation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Edoxaban Pill; Subjects will be taking edoxaban 30 or 60 mg; Other Names: Lixiana; edoxaban tosylate monhydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Collaborators: Servier
• Investigators: Principal Investigator: Katia Dyrda, MD, Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2019
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Estimated): February 26, 2024
• Last Update Submitted That Met QC Criteria: February 23, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Atrial Fibrillation; Heart Valve Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Edoxaban
• Other Study ID Numbers: MHICC-2017-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No