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

Valvular Heart Disease Clinical Trial

— CAPTURE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03488420
• Other study ID #: MHICC-2017-001
• Status: Active, not recruiting
• Start date: April 30, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: February 2024
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 133
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation and Flutter
• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Drug:
• Edoxaban Pill
Subjects will be taking edoxaban 30 or 60 mg

Locations

Country	Name	City	State
Canada	CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby	Granby	Quebec
Canada	CISSS de la Montérégie Centre	Greenfield Park	Quebec
Canada	CISSS de Laval	Laval	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	IUCPQ	Québec	Quebec
Canada	CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski	Rimouski	Quebec
Canada	CISSS de Chaudière-Appalaches - Hopital Saint-Georges	Saint-Georges	Quebec
Canada	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	CIUSSS de la Mauricie-et-du-Centre-du-Québec	Trois-Rivières	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Montreal Heart Institute	Servier

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)		2 years
Primary	Cognitive function using the Montreal Cognitive Assessment (MoCA) test		2 years
Primary	Compliance of subjects to edoxaban treatment		2 years
Primary	Reasons for choosing edoxaban and reasons for the dosage		2 years
Primary	Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)		2 years
Primary	Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)		2 years
Primary	Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)		2 years
Primary	Death (CV and non-CV)		2 years
Primary	Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban		2 years
Primary	Physician satisfaction with regards to edoxaban treatment		2 years