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

April 1, 2024 updated by: Kansas City Heart Rhythm Research Foundation
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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Recruiting
        • Menorah Medical Center
        • Contact:
          • Donita Atkins
      • Overland Park, Kansas, United States, 66215
        • Recruiting
        • Overland Park Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Naga Venkata K. Pothineni
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Kansas City Heart Rhythm Institute - Roe Clinic
        • Contact:
        • Principal Investigator:
          • Naga Venkata K. Pothineni, MD
    • Missouri
      • Independence, Missouri, United States, 64057
        • Recruiting
        • Centerpoint Medical Center
        • Contact:
          • Donita Atkins
      • Independence, Missouri, United States, 64057
        • Recruiting
        • Centerpoint Medical Center Clinic
        • Contact:
          • Donita Atkins
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center Clinic
        • Contact:
        • Principal Investigator:
          • Naga Venkata K. Pothineni, MD
      • Kansas City, Missouri, United States, 64032
        • Recruiting
        • Research Medical Center
        • Contact:
        • Principal Investigator:
          • Naga Venkata K. Pothineni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
No.of patients with arrhythmia recurrence
Time Frame: 12 Months
No of patients with arrhythmia recurrence
12 Months
No.of patients with redo ablation
Time Frame: 12 Months
No of patients with redo ablation
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Dhanunjaya Lakkireddy, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

September 1, 2024

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 8, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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