NCT06500988 · Johns Hopkins University
Mobile Health Technology-Enabled AFib Management
(mTECH Afib)
What this study is about
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 randomly assigned clinical trial (RCT). A pilot study assessing feasibility and retention of the intervention was previously conducted (NCT05400837)
View original scientific description
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).
Interventions
COMBINATION_PRODUCT
Corrie Virtual Atrial Fibrillation Management Program
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
Pharmaceutical Research & Manufacturers Of America Foundation, Apple Inc., Itamar-Medical, Israel
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations