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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback | Other | Study team members will conduct interviews with subjects to gather feedback on Atrial Fibrillation experiences |
|
| Measure | Description | Time Frame |
|---|---|---|
| Interview Process | The number of subjects to complete the interview process | baseline |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Victor M Montori | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38178866 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nonvalvular Chronic Atrial Fibrillation (DA4AFib) | Subjects who were scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota Study team members conducted interviews with subjects to gather feedback on Atrial Fibrillation experiences |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nonvalvular Chronic Atrial Fibrillation (DA4AFib) | Subjects who were scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota Study team members conducted interviews with subjects to gather feedback on Atrial Fibrillation experiences |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Interview Process | The number of subjects to complete the interview process | Posted | Count of Participants | Participants | baseline |
|
|
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nonvalvular Chronic Atrial Fibrillation (DA4AFib) | Subjects who were scheduled for Nonvalvular Chronic Atrial Fibrillation (DA4AFib) treatment at Mayo Clinic Rochester and Mayo Clinic Health System sites in Minnesota Study team members conducted interviews with subjects to gather feedback on Atrial Fibrillation experiences |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Victor Montori | Mayo Clinic | 507-284-1920 | montori.victor@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2019 | Sep 24, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2019 | Jun 8, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |