Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF Study
NCT ID: NCT06352060
Last Updated: 2025-04-18
Study Results
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View full resultsBasic Information
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COMPLETED
598 participants
OBSERVATIONAL
2018-01-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Participants with ICM
Patients who underwent ICM insertion
No intervention or administration will be performed due to the observational nature of the study
Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
Non-ICM Participants
Patients with traditional monitoring methods
No intervention or administration will be performed due to the observational nature of the study
Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
Interventions
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No intervention or administration will be performed due to the observational nature of the study
Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.
Eligibility Criteria
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Inclusion Criteria
* Present for management of AF
* ICM is inserted at the discretion of the treating physician
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kansas City Heart Rhythm Research Foundation
OTHER
Responsible Party
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Principal Investigators
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Dhanunjaya Lakkireddy
Role: PRINCIPAL_INVESTIGATOR
Kansas City Heart Rhythm Institute
Locations
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Menorah Medical Center
Overland Park, Kansas, United States
Kansas City Heart Rhythm Institute - Roe Clinic
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Centerpoint Medical Center Clinic
Independence, Missouri, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center Clinic
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Countries
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References
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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.
Reiffel 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.
Svendsen 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.
Reiffel 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KCHRRF_MONITOR AF_030
Identifier Type: -
Identifier Source: org_study_id
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