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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with ICM | Patients who underwent ICM insertion |
| |
| Non-ICM Participants | Patients with traditional monitoring methods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes in Participants With ICM and Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. |
| Total CV-related Hospital Stay Duration, Days |
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Inclusion Criteria
Exclusion Criteria
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Adult patients with atrial fibrillation management either with ICM or routine management
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy | Kansas City Heart Rhythm Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States | ||
| Kansas City Heart Rhythm Institute - Roe Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14715182 | Background | 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. | |
| 31862084 | 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. |
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598 patients, with 299 in the non-ICM and ICM groups, respectively were included in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With ICM | Patients who underwent ICM insertion 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2024 |
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| 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. |
| Overland Park |
| Kansas |
| 66211 |
| United States |
| Overland Park Regional Medical Center | Overland Park | Kansas | 66215 | United States |
| Centerpoint Medical Center Clinic | Independence | Missouri | 64057 | United States |
| Centerpoint Medical Center | Independence | Missouri | 64057 | United States |
| Research Medical Center Clinic | Kansas City | Missouri | 64032 | United States |
| Research Medical Center | Kansas City | Missouri | 64032 | United States |
| 34469766 | 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. |
| 28842973 | 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. |
| Non-ICM Participants |
Patients with traditional monitoring methods 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With ICM | Patients who underwent ICM insertion 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. |
| BG001 | Non-ICM Participants | Patients with traditional monitoring methods 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| Parosysmal Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Persistent Atrial Fibrillation | Count of Participants | Participants |
| ||||||||||||||||
| Baseline AAD Use | Count of Participants | Participants |
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| Stroke / TIA | Count of Participants | Participants |
| ||||||||||||||||
| Compensated heart failure (EF <35%) | Count of Participants | Participants |
| ||||||||||||||||
| Coronary artery disease | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. |
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| Secondary | Clinical Outcomes in Participants With ICM and Non-ICM Participants | Clinical Outcomes in Participants With ICM and Non-ICM Participants at 12 months | Posted | Count of Participants | Participants | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. |
|
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| Secondary | Total CV-related Hospital Stay Duration, Days | Posted | Mean | Standard Deviation | Days | 12 Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up. |
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12-Months. Data collection was 1 month examining participants retrospectively at a 1 year follow-up.
All-Cause Mortality events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With ICM | Patients who underwent ICM insertion 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. | 0 | 0 | 7 | 299 | 2 | 299 |
| EG001 | Non-ICM Participants | Patients with traditional monitoring methods 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. | 0 | 0 | 24 | 299 | 9 | 299 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AF-related hospitalization | Cardiac disorders | Non-systematic Assessment |
| ||
| HF-related hospitalization | Cardiac disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke/TIA | Cardiac disorders | Non-systematic Assessment |
| ||
| Major bleeding episodes | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dhanunjaya Lakkireddy | Kansas City Heart Rhythm Institute | 913-934-4300 | dlakkireddy@gmail.com |
| Feb 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| African American |
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| Hispanic |
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| Other |
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| Number of patients with freedom from AAD use |
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