Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
248 participants
INTERVENTIONAL
2025-06-03
2028-06-30
Brief Summary
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Researchers plan to evaluate the effectiveness of this novel digital toolkit in improving quality of life and decreasing AFib burden in a randomized clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Corrie Virtual Atrial Fibrillation Management Program
Multicomponent virtual atrial fibrillation management program
Corrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Usual Care
Receives usual care. Usual care is defined as care according to the patients care team's standard practice
No interventions assigned to this group
Interventions
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Corrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
3. BMI (Body Mass Index) ≥ 27.0
Exclusion Criteria
2. Severe valvular disease
3. Moderate mitral valve stenosis
4. Prior cardiac surgery
5. Presence of implanted cardiac device
6. History of cardiac arrest
7. Left ventricular ejection fraction (LVEF) ≤ 35%
8. Life expectancy \< 1 year
9. Non-English speaking
10. Treating clinician deems unsafe for exercise
11. Any other reason that makes patient unsuitable for study at the discretion of the PI
18 Years
ALL
No
Sponsors
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Pharmaceutical Research & Manufacturers Of America Foundation
UNKNOWN
Apple Inc.
INDUSTRY
Itamar-Medical, Israel
INDUSTRY
Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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David Spragg, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB00453569
Identifier Type: -
Identifier Source: org_study_id
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