Status:
RECRUITING
Mobile Health Technology-Enabled AFib Management
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Pharmaceutical Research & Manufacturers Of America Foundation
Apple Inc.
Conditions:
Atrial Fibrillation
Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective of this proposal is to evaluate the effect on quality of life of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an activ...
Eligibility Criteria
Inclusion
- Aged 18 or older at time of consent
- Diagnosis of paroxysmal (Afib lasting less than 7 days) or persistent (7 days or longer) atrial fibrillation
- BMI (Body Mass Index) ≥ 27.0
Exclusion
- Permanent Afib (decision has been made not to attempt sinus rhythm)
- Severe valvular disease
- Moderate mitral valve stenosis
- Prior cardiac surgery
- Presence of implanted cardiac device
- History of cardiac arrest
- Left ventricular ejection fraction (LVEF) ≤ 35%
- Life expectancy \< 1 year
- Non-English speaking
- Treating clinician deems unsafe for exercise
- Any other reason that makes patient unsuitable for study at the discretion of the PI
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT06500988
Start Date
June 3 2025
End Date
June 1 2028
Last Update
June 10 2025
Active Locations (2)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
2
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287