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Completed

NCT Number: NCT06352060

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansas City Heart Rhythm Institute - Roe Clinic, Overland Park, Kansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention or administration will be performed due to the observational nature of the study

Other

Charts of patients enrolled in the study will be reviewed for an initial monitoring method and any changes in management.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

    Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months

  2. 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.

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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