Dynamic Data-Driven Management of Atrial Fibrillation Using Implantable Cardiac Monitors: The MONITOR-AF 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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: No intervention or administration will be performed due to the observational nature of the study

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 Type: Observational
• Enrollment (Actual): 598

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center
    • Overland Park, Kansas, United States, 66211
      • Kansas City Heart Rhythm Institute - Roe Clinic
  • Missouri
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center Clinic
    • Kansas City, Missouri, United States, 64032
      • Research Medical Center Clinic
    • Kansas City, Missouri, United States, 64032
      • Research Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with atrial fibrillation management either with ICM or routine management

Description

Inclusion Criteria

• Patients > 18 years of age
• Present for management of AF
• ICM is inserted at the discretion of the treating physician

Exclusion Criteria

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with ICM; Patients who underwent ICM insertion	Other: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Outcomes in Participants With ICM and Non-ICM Participants	Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months	12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
Total CV-related Hospital Stay Duration, Days		12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Research Foundation
• Investigators: Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Publications and helpful links

General 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.
• 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.
• 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. Erratum In: Lancet. 2021 Oct 23;398(10310):1486. doi: 10.1016/S0140-6736(21)02090-0.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: April 1, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: KCHRRF_MONITOR AF_030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No