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NCT06500988Recruiting

Mobile Health Technology-Enabled AFib Management

Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2

Source: ClinicalTrials.gov · Last updated 20 Apr 2026

Brief summary (registry, in English)

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 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 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)

Status (registry)
Recruiting
Study type
Interventional
Enrollment
248 (estimated)
First submitted
8 Jul 2024
Start date
3 Jun 2025
Primary completion date
Jun 2028
Lead sponsor
Johns Hopkins University
NCT number
NCT06500988

What you commit to

  • Study type: Interventional
  • Planned participants: 248
  • From 3 Jun 2025 to the primary completion date, Jun 2028
  • 2 sites 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

  • Prior cardiac surgery

Other illness

  • Severe valvular disease
  • Presence of implanted cardiac device
  • History of cardiac arrest

Lab values

  • Left ventricular ejection fraction (LVEF) ≤ 35%

Other

  • Permanent Afib (decision has been made not to attempt sinus rhythm)
  • Moderate mitral valve stenosis
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Johns Hopkins Bayview Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting
Johns Hopkins Outpatient Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.