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This is a prospective, non-randomized, multi-center, real-world post-market study to collect and evaluate data regarding the performance of the enhanced atrial fibrillation detection algorithm of the Assert-IQTM Implantable Cardiac Monitor (ICM) device.
The study's intent is to generate long-term real-world data on the safety, performance, and clinical benefits of the Assert-IQTM ICM device system. This clinical investigation is sponsored by Abbott Medical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects successfully implanted with an Abbott Assert-IQ ICM device | Holter monitoring in subjects successfully implanted with an Abbott Assert-IQ ICM device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holter monitoring in patients who have been successfully implanted with an Abbott Assert-IQ ICM device | Device | All enrolled subjects who meet eligibility criteria will undergo an attempted implant within 30 days of consent. After successful device implant, subjects will be followed at 1 and 12 months. Subjects will be fitted with a Holter monitor during the 1m follow-up visit and will complete a minimum of 72 hours and maximum of up to 7 days of Holter monitoring. |
| Measure | Description | Time Frame |
|---|---|---|
| Episode-based AF detection performance metrics | Episode-based AF detection performance metrics of the Assert-IQTM ICM device compared to that of simultaneous Holter monitoring in 150 subjects who had received the Assert-IQTM ICM device as part of their standard of care. | Holter monitor worn by the subjects over a minimum 72-hour and up to 7 days period. An AF episode is defined as AF has greater or equal to 2 minutes (≥2 minutes) in duration. |
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Inclusion Criteria:
Patients must meet ALL study inclusion criteria to participate in the study.
Exclusion Criteria:
If ANY study exclusion criteria are met, the patient is excluded from the study and cannot be enrolled (recruitment failure).
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Subjects who are diagnosed with symptomatic, drug-refractory paroxysmal or persistent AF, and are scheduled to receive an Assert-IQTM ICM device
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| Name | Affiliation | Role |
|---|---|---|
| Kwangdeok Lee, PhD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92103 | United States | ||
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|
| Orlando Health |
| Orlando |
| Florida |
| 32806 |
| United States |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | United States |
| Trinity Health-Michigan d/b/a Michigan Heart | Ann Arbor | Michigan | 48106 | United States |
| St. Peter's Health Partners Medical Associates, PC | Albany | New York | 12205 | United States |
| Trident Medical Center | Charleston | South Carolina | 29406 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Shannon Clinic | San Angelo | Texas | 76903 | United States |
| Methodist Texsan Hospital | San Antonio | Texas | 78201 | United States |
| Heart Rhythm Associates | The Woodlands | Texas | 77380 | United States |
| Aurora Medical Group | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D013575 | Syncope |
| D004417 | Dyspnea |
| D004244 | Dizziness |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012678 | Sensation Disorders |
| D000075224 | Cardiac Conduction System Disease |
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| ID | Term |
|---|---|
| D015716 | Electrocardiography, Ambulatory |
| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004568 | Electrodiagnosis |
| D018670 | Monitoring, Ambulatory |
| D008991 | Monitoring, Physiologic |
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