Atrial Fibrillation Clinical Trial
Official title:
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Kansas City Heart Rhythm Research Foundation |
United States,
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
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 |
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