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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06352060
• Other study ID #: KCHRRF_MONITOR AF_030
• Status: Recruiting
• Start date: April 2024
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Kansas City Heart Rhythm Research Foundation
• Contact: Donita Atkins
• Phone: 8166511969
• Email: datkins[@]kchrf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Centerpoint Medical Center	Independence	Missouri
United States	Centerpoint Medical Center Clinic	Independence	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Research Medical Center Clinic	Kansas City	Missouri
United States	Kansas City Heart Rhythm Institute - Roe Clinic	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Kansas City Heart Rhythm Research Foundation

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No.of patients with arrhythmia recurrence	No of patients with arrhythmia recurrence	12 Months
Primary	No.of patients with redo ablation	No of patients with redo ablation	12 Months