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

NCT03488420 | Completed FDA Drug

• 1 other identifier: MHICC-2017-001
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Atrial Fibrillation and Flutter; Valvular Heart Disease

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

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

Interventions

Edoxaban Pill DRUG

Subjects will be taking edoxaban 30 or 60 mg

Also known as: Lixiana, edoxaban tosylate monhydrate

Atrial Fibrillation and/or Atrial Flutter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Montreal Heart Institute: lead
• Servier: collaborator

Study Sites (9)

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

Granby, Quebec, Canada

Location

CISSS de la Montérégie Centre

Greenfield Park, Quebec, Canada

Location

CISSS de Laval

Laval, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

Location

IUCPQ

Québec, Quebec, Canada

Location

CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski

Rimouski, Quebec, Canada

Location

CISSS de Chaudière-Appalaches - Hopital Saint-Georges

Saint-Georges, Quebec, G5Y 4T8, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

CIUSSS de la Mauricie-et-du-Centre-du-Québec

Trois-Rivières, Quebec, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Heart Valve Diseases

Interventions

edoxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Katia Dyrda, MD

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 5, 2018
• Study Start: April 30, 2019
• Primary Completion: March 21, 2025
• Study Completion: April 3, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)