Valvular Heart Disease Clinical Trial
— CAPTUREOfficial title:
Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)
Verified date | February 2024 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute | Servier |
Canada,
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 |
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