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

N/ACompletedNCT06352060

Kansas City Heart Rhythm Research Foundation598 enrolled

Overview

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.

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

598

Conditions

Atrial Fibrillation

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

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

Outcomes

Primary Outcomes

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

Time frame: 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.

Secondary Outcomes

Clinical Outcomes in Participants With ICM and Non-ICM Participants

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

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.

Data from ClinicalTrials.gov

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