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Due to slow enrollment.
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The purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (AF) based on information from a pacemaker or implantable cardioverter defibrillator (ICD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor | |
| Tailored Anticoagulation (TAC) | Experimental | Anticoagulation was initiated or discontinued based on atrial tachycardia / atrial fibrillation (AT/AF) burden as assessed through frequent remote transmissions via Merlin.net. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug (Direct thrombin or Factor Xa inhibitor) | Other | Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden). |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cumulative Days on Anticoagulation | To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden. | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Zimetbaum, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeffrey Goodman, MD | Los Angeles | California | 90048 | United States | ||
| Northwestern Memorial Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anticoagulation Taken as Prescribed by Doctor | Anticoagulation presciption will be taken per physician's discretion |
| FG001 | Anticoagulation to be Stopped/Started Per Device Information |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Chicago |
| Illinois |
| 60611 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Sparrow Research Institute | Lansing | Michigan | 48912 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 76011 | United States |
| Samaritan Heart and Vascular Institute | Corvallis | Oregon | 97330 | United States |
| Jefferson Heart Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Allegheny Singer Research Institute | Pittsburgh | Pennsylvania | 15212 | United States |
| STAR Clinical Trials, LLC / Cardiology Clinic of San Antonio | San Antonio | Texas | 78229 | United States |
Other: The physician will manage the patient's anticoagulation medication by weekly remote monitoring device transmissions
Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Remote transmissions were scheduled per each institution's device monitoring protocol. Anticoagulation was initiated/discontinued based on standard of care/guidelines as prescribed by doctor. |
| BG001 | Tailored Anticoagulation | Tailored Anticoagulation (TAC): Anticoagulation to be stopped/started per device information. Patients sent in biweekly remote transmissions, automatic alert-triggered transmissions for AT/AF burden above a set threshold, and unscheduled patient-activated transmissions as needed. Drug (Direct thrombin or Factor Xa inhibitor): Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden). |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Total Cumulative Days on Anticoagulation | To assess the reduction in time on anticoagulation, the cumulative total number of days on anticoagulation for each group throughout the follow-up period was determined. This study was designed as a pilot/feasibility study and therefore was not powered to detect thromboembolic events. Per study protocol, all patients completed a 30 day run-in period following enrollment during which anticoagulation could not be stopped regardless of AT/AF burden. | After a 30-day run-in period during which anticoagulation use could not be stopped per study protocol, a total of 14,826 cumulative days of monitoring were completed. | Posted | Number | days on anticoagulation | one year |
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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 | Anticoagulation Taken as Prescribed by Doctor | Anticoagulation medication was per doctor's discretion | 0 | 16 | 3 | 16 | 5 | 16 |
| EG001 | Anticoagulation to be Stopped/Started Per Device Information | Anticoagulation medication was based on patient's AT/AF information from device | 2 | 48 | 8 | 48 | 9 | 48 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemorrahagic event | Gastrointestinal disorders | Patient With Hematemesis And Epigastric Pain. Gi Consult. Egd With Ulcer In Funders Which Was Endoclipped. Continued On Aspirin And Apixaban. Avoid Nsaid. |
| ||
| DECOMPENSATED HF | Cardiac disorders |
| |||
| ATRIAL ARRHYTHMIA | Cardiac disorders |
| |||
| HEMORRHAGIC EVENT | Nervous system disorders |
| |||
| INFECTION | Infections and infestations |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL ARRHYTHMIA | Cardiac disorders |
| |||
| HEMORRHAGIC EVENT | General disorders |
| |||
| HEMORRHAGIC EVENT | Vascular disorders |
| |||
| LV Thrombus | Cardiac disorders |
| |||
| RIB FRACTURE | Injury, poisoning and procedural complications |
| |||
| HEMORRHAGIC EVENT | Gastrointestinal disorders |
| |||
| PNEUMONIA | Infections and infestations |
| |||
| DIVERTICULITIS | Gastrointestinal disorders |
| |||
| SYNCOPE | General disorders |
| |||
| CORONARY ARTERY DISEASE | Cardiac disorders |
| |||
| OVERSENSING | Product Issues |
| |||
| RADIAL HEAD FRACTURE | Injury, poisoning and procedural complications |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grant Kim | ABBOTT | 818-493-3147 | gkim@sjm.com |
| 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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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D065427 | Factor Xa Inhibitors |
| ID | Term |
|---|---|
| D000991 | Antithrombins |
| D015842 | Serine Proteinase Inhibitors |
| D011480 | Protease Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000925 | Anticoagulants |
| D006401 | Hematologic Agents |
| D045506 | Therapeutic Uses |
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| >=65 years |
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| Male |
|