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

NCT06352060 | Completed Results

• 1 other identifier: KCHRRF_MONITOR AF_030
• Study Type: observational
• Target: 598
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Clinical Outcomes in Participants With ICM and Non-ICM Participants

  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.

Study Arms (2)

Participants with ICM

Patients who underwent ICM insertion

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

Non-ICM Participants

Patients with traditional monitoring methods

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

Interventions

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.

Non-ICM Participants; Participants with ICM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kansas City Heart Rhythm Research Foundation: lead

Study Sites (7)

Menorah Medical Center

Overland Park, Kansas, 66209, United States

Location

Kansas City Heart Rhythm Institute - Roe Clinic

Overland Park, Kansas, 66211, United States

Location

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

Location

Centerpoint Medical Center Clinic

Independence, Missouri, 64057, United States

Location

Centerpoint Medical Center

Independence, Missouri, 64057, United States

Location

Research Medical Center Clinic

Kansas City, Missouri, 64032, United States

Location

Research Medical Center

Kansas City, Missouri, 64032, United States

Location

Related Publications (4)

• 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.

  PMID: 14715182 BACKGROUND

• 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.

  PMID: 31862084 BACKGROUND

• 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.

  PMID: 34469766 BACKGROUND

• 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.

  PMID: 28842973 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dhanunjaya Lakkireddy
• Organization: Kansas City Heart Rhythm Institute

dlakkireddy@gmail.com

913-934-4300

Study Officials

• Dhanunjaya Lakkireddy

  Kansas City Heart Rhythm Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: April 8, 2024
• Study Start: January 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 18, 2025
• Results First Posted: April 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)