Atrial Fibrillation and FlutterCAPTURENCT03488420
Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE
An observational study of Atrial Fibrillation and Flutter and Valvular Heart Disease, run by Montreal Heart Institute at 9 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter, Valvular Heart Disease
- What is being tested?
- Edoxaban Pill
- Type of treatment
- Pill or oral medicine
- How many people
- 136 participants
- Where
- 9 sitesCanada
- Study dates
- 30 Apr 2019to 3 Apr 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby
Granby, Quebec
CISSS de la Montérégie Centre
Greenfield Park, Quebec
CISSS de Laval
Laval, Quebec
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
IUCPQ
Québec, Quebec
CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski
Rimouski, Quebec
CISSS de Chaudière-Appalaches - Hopital Saint-Georges
Saint-Georges, Quebec, G5Y 4T8
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
CIUSSS de la Mauricie-et-du-Centre-du-Québec
Trois-Rivières, Quebec
About this study
Official title: 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.
Read the 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.
- Being tested
- Edoxaban Pill
- Medical subject headings
- Atrial Fibrillation, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edoxaban PillDrug
Also called Lixiana, edoxaban tosylate monhydrate
Subjects will be taking edoxaban 30 or 60 mg
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Edoxaban Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
Measured: 2 years
Cognitive function using the Montreal Cognitive Assessment (MoCA) test
Measured: 2 years
Compliance of subjects to edoxaban treatment
Measured: 2 years
Reasons for choosing edoxaban and reasons for the dosage
Measured: 2 years
Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
Measured: 2 years
Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
Measured: 2 years
Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
Measured: 2 years
Death (CV and non-CV)
Measured: 2 years
Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
Measured: 2 years
Physician satisfaction with regards to edoxaban treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start30 Apr 2019
- Primary completion21 Mar 2025
- Study completion3 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Sponsor
- Investigators
- Katia Dyrda, MD, Principal investigator, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488420
- Sponsor's protocol ID
- MHICC-2017-001
- Acronym
- CAPTURE
- Status last verified
- Apr 2025
- First submitted
- 20 Mar 2018
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)
- ClinicalTrials.gov ID
- NCT03488420
- Acronym / sponsor ID
- CAPTURE / MHICC-2017-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 3 Apr 2025 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation and/or Atrial Flutter | – | Drug: Edoxaban PillSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edoxaban PillAlso: Lixiana, edoxaban tosylate monhydrateSubjects will be taking edoxaban 30 or 60 mg | Drug | Atrial Fibrillation and/or Atrial Flutter |
Primary outcome
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
Time frame: 2 years
Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)
Time frame: 2 years
Cognitive function using the Montreal Cognitive Assessment (MoCA) test
Time frame: 2 years
Compliance of subjects to edoxaban treatment
Time frame: 2 years
Reasons for choosing edoxaban and reasons for the dosage
Time frame: 2 years
Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)
Time frame: 2 years
Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)
Time frame: 2 years
Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)
Time frame: 2 years
Death (CV and non-CV)
Time frame: 2 years
Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban
Time frame: 2 years
Physician satisfaction with regards to edoxaban treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katia Dyrda, MD principal investigator
Montreal Heart Institute
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Flutter and Valvular Heart Disease, run by Montreal Heart Institute at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 2 years). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.