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NCT Number: NCT06500988

Mobile Health Technology-Enabled AFib Management

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)

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Corrie Virtual Atrial Fibrillation Management Program

Combination Product

Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit

Primary outcomes

  1. Participants Freedom from documented atrial tachyarrhythmia

    Time frame: 91 to 365 days

    Freedom from documented atrial tachyarrhythmia (atrial fibrillation/atrial flutter/atrial tachycardia) episodes of ≥30 seconds between 91 and 365 days after catheter ablation, on or off antiarrhythmic drugs.

Secondary outcomes

  1. Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)

    Time frame: 365 days

    Quality of Life, measured by validated Atrial Fibrillation Effect on Quality of Life (AFEQT) score. Score ranges from 0 to 100 with higher scores signifying better quality of life

  2. AFib burden (percentage of time)

    Time frame: 91 to 365 days

    Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation

  3. Participants Freedom from atrial tachyarrhythmia off medication

    Time frame: 91 to 365 days

    Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications.

  4. Participants Freedom from atrial tachyarrhythmia on or off medications

    Time frame: 1 day to 365 days

    Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications.

  5. Incidence of hospitalizations, emergency room visits, deaths

    Time frame: 1 to 365 days

    Safety (composite of hospitalizations, emergency room visits, deaths)

Study contacts

Contact information is provided by the study sponsor or research team.

Nino Isakadze

CONTACT

[email protected]

410-955-5999

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Apple Inc.
  • Itamar-Medical, Israel
  • Pharmaceutical Research & Manufacturers Of America Foundation

Registry information

Official study title

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

Acronym: mTECH Afib

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 15, 2024
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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