Status:
COMPLETED
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
Lead Sponsor:
Johns Hopkins University
Conditions:
Atrial Fibrillation
Behavior
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The overall objective of this proposal is to evaluate the feasibility of a comprehensive digital atrial fibrillation (AFib) management tool that will empower patients to a) take an active role in lear...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 18 years or older
- Non- valvular Paroxysmal Atrial Fibrillation
- Exclusion Criteria
- Non-English speaking
- Has previously been evaluated by a cardiologist or electrophysiologist
- Mitral Stenosis
- Presence of Artificial Heart Valve
- Severe valvular disease (any)
- Physical disability that would preclude technology use, safe and adequate exercise performance
- Hearing or Visual Impairment that would preclude technology use
- History of fall one or more times in the last year
- Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
- Known aortic dissection
- Severe resting arterial hypertension (SBP \>200 mmHg or diastolic BP \>110mmHg) upon enrollment (obtained during clinic visit)
- Mental impairment leading to inability to cooperate with study procedures
- Untreated high degree atrioventricular block
- Atrial fibrillation with rapid ventricular rate (Resting heart rate at enrollment visit \>110) upon enrollment (obtained during clinic visit)
- History of cardiac arrest, sudden death
- MI or cardiac surgery complications of cardiogenic shock and/or congestive heart failure (CHF) and/or signs/symptoms of post-procedure ischemia
- Left ventricular ejection fraction \<40%
- Clinically significant depression
- Presence of implanted cardiac device
- Incomplete revascularization procedure
- Pregnancy
- Previous open-heart surgery
- Unsafe to participate in the program as per treating clinician
Exclusion
Key Trial Info
Start Date :
June 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05400837
Start Date
June 26 2023
End Date
May 23 2024
Last Update
July 3 2025
Active Locations (1)
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1
Johns Hopkins University
Baltimore, Maryland, United States, 21287