Atrial Fibrillation(DA4AFib)NCT03744936
Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
An observational study of Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Feedback
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2018to 6 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Encounters of subjects scheduled for AF (Atrial Fibrillation) treatment will be observed (by a study team member and/or using a video recording device) at Mayo Clinic Rochester and may be observed at Mayo Clinic Health System sites in Minnesota.
- Must be 18 or older
- Must have an appointment for Atrial Fibrillation
- Must not have dementia
- Must not have severe hearing or vision impairment Patients will be given a written consent Guests that accompany patients will be given an oral consent KER unit PAG members will be given an oral consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.
- Conditions
- Atrial Fibrillation
- Being tested
- Feedback
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeedbackOther
Study team members will conduct interviews with subjects to gather feedback on Atrial Fibrillation experiences
| Study group | Role | What they receive |
|---|---|---|
| Nonvalvular Chronic Atrial Fibrillation (DA4AFib) | Subjects who are scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota Receives: Other: Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview Process
The number of subjects to complete the interview process
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start4 Oct 2018
- Primary completion6 Feb 2020
- Study completion6 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Victor Montori, Mayo Clinic
- Investigators
- Victor M Montori, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744936
- Sponsor's protocol ID
- 18-007275
- Acronym
- (DA4AFib)
- Status last verified
- Dec 2024
- First submitted
- 13 Nov 2018
- Last updated
- 24 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones AE, McCarty MM, Cameron KA, Cavanaugh KL, Steinberg BA, Passman R, Kansal P, Guzman A, Chen E, Zhong L, Fagerlin A, Hargraves I, Montori VM, Brito JP, Noseworthy PA, Ozanne EM. Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation. MDM Policy Pract. 2023 Jun 21;8(1):23814683231178033. doi: 10.1177/23814683231178033. eCollection 2023 Jan-Jun.
PubMed 38178866
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aids for Patients With Nonvalvular Chronic Atrial Fibrillation (DA4AFib)
- ClinicalTrials.gov ID
- NCT03744936
- Acronym / sponsor ID
- (DA4AFib) / 18-007275
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 4 Oct 2018 (actual)
- Primary completion
- 6 Feb 2020 (actual)
- Study completion
- 6 Feb 2020 (actual)
- First posted
- 19 Nov 2018 (actual)
- Results
- Posted 24 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers are observing subject and clinician interaction in order to develop future education materials that will help patients and clinicians discuss atrial fibrillation and options to treat it.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nonvalvular Chronic Atrial Fibrillation (DA4AFib) | – | Other: FeedbackSubjects who are scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Encounters of subjects scheduled for AF (Atrial Fibrillation) treatment will be observed (by a study team member and/or using a video recording device) at Mayo Clinic Rochester and may be observed at Mayo Clinic Health System sites in Minnesota.
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 |
|---|---|---|
| FeedbackStudy team members will conduct interviews with subjects to gather feedback on Atrial Fibrillation experiences | Other | Nonvalvular Chronic Atrial Fibrillation (DA4AFib) |
Primary outcome
Interview Process
Time frame: baseline
The number of subjects to complete the interview process
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38178866Jones AE, McCarty MM, Cameron KA, Cavanaugh KL, Steinberg BA, Passman R, Kansal P, Guzman A, Chen E, Zhong L, Fagerlin A, Hargraves I, Montori VM, Brito JP, Noseworthy PA, Ozanne EM. Development of Complementary Encounter and Patient Decision Aids for Shared Decision Making about Stroke Prevention in Atrial Fibrillation. MDM Policy Pract. 2023 Jun 21;8(1):23814683231178033. doi: 10.1177/23814683231178033. eCollection 2023 Jan-Jun.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Victor M Montori principal investigator
Mayo Clinic
1 site 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, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Yes. Results are posted in the registry (first posted 24 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Interview Process (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03744936, which also lists 1 linked publication.
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 24 Jan 2025.