Atrial FibrillationNCT06352060
Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
An observational study of Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 7 sites in United States.
Trial summary
Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 598 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jan 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: Adult patients with atrial fibrillation management either with ICM or routine management
Who may be able to join
- Patients > 18 years of age
- Present for management of AF
- ICM is inserted at the discretion of the treating physician
Who cannot join
- Patients < 18 years of age
- Presence of a permanent pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy
- Unable to tolerate ICM or traditional monitoring with ECG, Holter, or MCOT monitoring
- Unable to tolerate AAD, OAC, and CA as part of AF standard of care
- ICM inserted for cryptogenic stroke or syncope
- Was not followed > 12 months
- CA performed for AF before ICM implant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Centerpoint Medical Center Clinic
Independence, Missouri, 64057
Centerpoint Medical Center
Independence, Missouri, 64057
Research Medical Center Clinic
Kansas City, Missouri, 64032
Research Medical Center
Kansas City, Missouri, 64032
Menorah Medical Center
Overland Park, Kansas, 66209
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, 66211
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
About this study
Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units.
Read the detailed description
Even with its increasing popularity and use, the impact of ICMs on AF (atrial fibrillation) management is still being determined and can even be conflicting. Furthermore, the use of ICM is dependent on physician preference. It is hypothesized that dynamic monitoring with ICMs is superior to conventional methods and should be used for all patients with AF. Thus, it aimed to measure the outcomes of using ICM versus more traditional approaches in patients with AF.
- Conditions
- Atrial Fibrillation
- Being tested
- No intervention or administration will be performed due to the observational nature of the study
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention or administration will be performed due to the observational nature of the studyOther
Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
| Study group | Role | What they receive |
|---|---|---|
| Participants with ICM | Patients who underwent ICM insertion Receives: Other: No intervention or administration will be performed due to the observational nature of the study | |
| Non-ICM Participants | Patients with traditional monitoring methods Receives: Other: No intervention or administration will be performed due to the observational nature of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Freedom From AF, OAC and AAD Use
Number of patients with freedom from AF, OAC and AAD Use after 12 months
Measured: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Secondary outcomes (2)
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months
Measured: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Total CV-related Hospital Stay Duration, Days
Measured: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kansas City Heart Rhythm Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dhanunjaya Lakkireddy, Principal investigator, Kansas City Heart Rhythm Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352060
- Sponsor's protocol ID
- KCHRRF_MONITOR AF_030
- Status last verified
- Jan 2025
- First submitted
- 29 Feb 2024
- Last updated
- 18 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027.
PubMed 14715182Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.
PubMed 31862084Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.
PubMed 34469766Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
PubMed 28842973Katapadi A, Chelikam N, Garg J, Gopinathannair R, Park P, Darden D, Pothineni NVK, Atkins D, Kabra R, Bommana S, Chung M, DiBiase L, Natale A, Lakkireddy D. Dynamic data-driven management of atrial fibrillation with implantable cardiac monitors: The MONITOR AF study. Heart Rhythm. 2025 Dec;22(12):3050-3056. doi: 10.1016/j.hrthm.2025.01.011. Epub 2025 Jan 16.
PubMed 39826639
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
- ClinicalTrials.gov ID
- NCT06352060
- Acronym / sponsor ID
- KCHRRF_MONITOR AF_030
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Kansas City Heart Rhythm Research FoundationUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 8 Apr 2024 (actual)
- Results
- Posted 18 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, multi-center, retrospective study to evaluate the use of ICM (implantable cardiac monitor) versus traditional, non-ICM (non-implantable cardiac monitor) methods such as ECGs (electrocardiogram), Holter, and mobile cardiac outpatient telemetry (MCOT) units.
Detailed description
Even with its increasing popularity and use, the impact of ICMs on AF (atrial fibrillation) management is still being determined and can even be conflicting. Furthermore, the use of ICM is dependent on physician preference. It is hypothesized that dynamic monitoring with ICMs is superior to conventional methods and should be used for all patients with AF. Thus, it aimed to measure the outcomes of using ICM versus more traditional approaches in patients with AF.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with ICM | – | Other: No intervention or administration will be performed due to the observational nature of the studyPatients who underwent ICM insertion |
| Non-ICM Participants | – | Other: No intervention or administration will be performed due to the observational nature of the studyPatients with traditional monitoring methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with atrial fibrillation management either with ICM or routine management
Key inclusion criteria (3 listed)
- Patients > 18 years of age
- Present for management of AF
- ICM is inserted at the discretion of the treating physician
Key exclusion criteria (7 listed)
- Patients < 18 years of age
- Presence of a permanent pacemaker, implantable cardiac defibrillator, or cardiac resynchronization therapy
- Unable to tolerate ICM or traditional monitoring with ECG, Holter, or MCOT monitoring
- Unable to tolerate AAD, OAC, and CA as part of AF standard of care
- ICM inserted for cryptogenic stroke or syncope
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 |
|---|---|---|
| No intervention or administration will be performed due to the observational nature of the studyCharts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management. | Other | Non-ICM Participants, Participants with ICM |
Primary outcome
Number of Patients With Freedom From AF, OAC and AAD Use
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Number of patients with freedom from AF, OAC and AAD Use after 12 months
2 secondary outcomes
Clinical Outcomes in Participants With ICM and Non-ICM Participants
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Total CV-related Hospital Stay Duration, Days
Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 14715182Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027.
- Background: PubMed 31862084Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Elkind MSV, Ziegler PD, Kaplon RE, Sherfesee L, Wachter R; REVEAL AF Investigators. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. 2020 Jan;219:128-136. doi: 10.1016/j.ahj.2019.07.016.
- Background: PubMed 34469766Svendsen JH, Diederichsen SZ, Hojberg S, Krieger DW, Graff C, Kronborg C, Olesen MS, Nielsen JB, Holst AG, Brandes A, Haugan KJ, Kober L. Implantable loop recorder detection of atrial fibrillation to prevent stroke (The LOOP Study): a randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1507-1516. doi: 10.1016/S0140-6736(21)01698-6. Epub 2021 Aug 29.
- Background: PubMed 28842973Reiffel JA, Verma A, Kowey PR, Halperin JL, Gersh BJ, Wachter R, Pouliot E, Ziegler PD; REVEAL AF Investigators. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. 2017 Oct 1;2(10):1120-1127. doi: 10.1001/jamacardio.2017.3180.
- Derived from this study: PubMed 39826639Katapadi A, Chelikam N, Garg J, Gopinathannair R, Park P, Darden D, Pothineni NVK, Atkins D, Kabra R, Bommana S, Chung M, DiBiase L, Natale A, Lakkireddy D. Dynamic data-driven management of atrial fibrillation with implantable cardiac monitors: The MONITOR AF study. Heart Rhythm. 2025 Dec;22(12):3050-3056. doi: 10.1016/j.hrthm.2025.01.011. Epub 2025 Jan 16.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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. This study is not recruiting at the moment.
Dhanunjaya Lakkireddy principal investigator
Kansas City Heart Rhythm Institute
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Kansas City Heart Rhythm Research Foundation at 7 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 7 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: finished, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Yes. Results are posted in the registry (first posted 18 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Freedom From AF, OAC and AAD Use (time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06352060, which also lists 5 linked publications.
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 18 Apr 2025.