NCT05400837Completed
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management
Patient Centered Mobile Health Technology Enabled Atrial Fibrillation Management: A Pilot Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 3 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 learning about AFib management options, starting and adhering to evidence-based therapies and lifestyle changes and b) to guide the patients during AFib episodes which are associated with anxiety and impairment in quality of life. Researchers plan to evaluate the feasibility and preliminary efficacy of this novel digital toolkit in improving quality of life and decreasing AFib burden in a pilot randomized clinical trial (RCT).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 27 May 2022
- Start date
- 26 Jun 2023
- Primary completion date
- 23 May 2024
- Lead sponsor
- Johns Hopkins University
- Diseases
- Atrial fibrillation
- NCT number
- NCT05400837
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 26 Jun 2023 to the primary completion date, 23 May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has previously been evaluated by a cardiologist or electrophysiologist
- Previous open-heart surgery
Other illness
- Presence of Artificial Heart Valve
- Severe valvular disease (any)
- Hearing or Visual Impairment that would preclude technology use
- History of fall one or more times in the last year
- 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
- 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
- Presence of implanted cardiac device
Lab values
- Left ventricular ejection fraction \<40%
Other
- Non-English speaking
- Mitral Stenosis
- Physical disability that would preclude technology use, safe and adequate exercise performance
- Hypertrophic obstructive cardiomyopathy with peak resting left ventricular outflow gradient of \>25 mmHg
- Known aortic dissection
- Untreated high degree atrioventricular block
- Clinically significant depression
- Incomplete revascularization procedure
- Pregnancy
- Unsafe to participate in the program as per treating clinician
Who the study is looking for
- 18 years or older
- Non- valvular Paroxysmal Atrial Fibrillation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.