Clinical trial NCT03488420: Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE
Official title: Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation and Flutter
Valvular Heart Disease
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Servier
First posted: 2018-04-05
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 2 years
measure: Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
timeFrame: 2 years
measure: Cognitive function using the Montreal Cognitive Assessment (MoCA) test
timeFrame: 2 years
measure: Compliance of subjects to edoxaban treatment
timeFrame: 2 years
measure: Reasons for choosing edoxaban and reasons for the dosage
timeFrame: 2 years
measure: Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
timeFrame: 2 years
measure: Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
timeFrame: 2 years
measure: Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
timeFrame: 2 years
measure: Death (CV and non-CV)
timeFrame: 2 years
measure: Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
timeFrame: 2 years
measure: Physician satisfaction with regards to edoxaban treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Granby
country: Canada
facility: CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby
state: Quebec
city: Greenfield Park
country: Canada
facility: CISSS de la Montérégie Centre
state: Quebec
city: Laval
country: Canada
facility: CISSS de Laval
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Québec
country: Canada
facility: IUCPQ
state: Quebec
city: Rimouski
country: Canada
facility: CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski
state: Quebec
city: Saint-Georges
country: Canada
facility: CISSS de Chaudière-Appalaches - Hopital Saint-Georges
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
city: Trois-Rivières
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Québec
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Katia Dyrda, MD
role: PRINCIPAL_INVESTIGATOR
References: