Atrial FibrillationmTECH AfibNCT06500988
Mobile Health Technology-Enabled AFib Management
A study testing Corrie Virtual Atrial Fibrillation Management Program in people with Atrial Fibrillation and Behavior, run by Johns Hopkins University at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Behavior
- What is being tested?
- Corrie Virtual Atrial Fibrillation Management Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Natalie Horstman, 443-839-0803, nhorstm3@jh.edu
- Recruiting
Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287
Natalie Horstman, 443-839-0803, nhorstm3@jh.edu
About this study
Official title: Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
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)
- Conditions
- Atrial Fibrillation, Behavior
- Being tested
- Corrie Virtual Atrial Fibrillation Management Program
- Keywords
- Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
- Medical subject headings
- Atrial Fibrillation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corrie Virtual Atrial Fibrillation Management ProgramCombination product
Intervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit
| Study group | Role | What they receive |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Multicomponent virtual atrial fibrillation management program Receives: Combination Product: Corrie Virtual Atrial Fibrillation Management Program |
| Usual Care | No intervention | Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants Freedom from documented atrial tachyarrhythmia
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.
Measured: 91 to 365 days
Secondary outcomes (5)
Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)
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
Measured: 365 days
AFib burden (percentage of time)
Atrial fibrillation burden (expressed as a percentage of time in atrial fibrillation) between 91 days and 365 days after catheter ablation
Measured: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia off medication
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between 91 days and 365 days after catheter ablation off medications.
Measured: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia on or off medications
Freedom from atrial tachyarrhythmia episodes ≥30 seconds in duration between day 1 and day 365 after catheter ablation, on and off medications.
Measured: 1 day to 365 days
Incidence of hospitalizations, emergency room visits, deaths
Safety (composite of hospitalizations, emergency room visits, deaths)
Measured: 1 to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start3 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Pharmaceutical Research & Manufacturers Of America Foundation, Apple Inc., Itamar-Medical, Israel
- Responsible party
- Sponsor
- Investigators
- Nino Isakadze, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500988
- Sponsor's protocol ID
- IRB00453569
- Acronym
- mTECH Afib
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Centered Mobile Health Technology-Enabled Atrial Fibrillation Management: Phase 2
- ClinicalTrials.gov ID
- NCT06500988
- Acronym / sponsor ID
- mTECH Afib / IRB00453569
- Conditions
- Atrial Fibrillation, Behavior
- Keywords
- Remote Patient Monitoring, Atrial Fibrillation, Risk Factor Modification, Digital Health, Mobile Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Pharmaceutical Research & Manufacturers Of America Foundation, Apple Inc., Itamar-Medical, Israel
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management Program | Experimental | Combination Product: Corrie Virtual Atrial Fibrillation Management ProgramMulticomponent virtual atrial fibrillation management program |
| Usual Care | No intervention | –Receives usual care. Usual care is defined as care according to the patients care team's standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corrie Virtual Atrial Fibrillation Management ProgramIntervention aims to implement a comprehensive digital atrial fibrilation guideline-recommended toolkit | Combination product | Corrie Virtual Atrial Fibrillation Management Program |
Primary outcome
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.
5 secondary outcomes
Quality of Life as assessed by Atrial Fibrillation Effect on Quality of Life (AFEQT)
Time frame: 365 days
AFib burden (percentage of time)
Time frame: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia off medication
Time frame: 91 to 365 days
Participants Freedom from atrial tachyarrhythmia on or off medications
Time frame: 1 day to 365 days
Incidence of hospitalizations, emergency room visits, deaths
Time frame: 1 to 365 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nino Isakadze, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corrie Virtual Atrial Fibrillation Management Program in people with Atrial Fibrillation and Behavior, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nino Isakadze (410-955-5999, nisakad1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants Freedom from documented atrial tachyarrhythmia (time frame: 91 to 365 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.