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The aim of the submodule study is to assess whether a high BMI may influence the sensing performance and the sECG quality of the BIOMONITOR.
This submodule of the BIO|STREAM.ICM registry specifically investigates the performance of the BIOMONITOR in a subset of obese patients with a BMI >30 kg/m2 in order to exclude any concerns regarding impaired ICM sensing performance. These concerns are founded in the increased distance between heart and device electrodes due to fat layers that may attenuate signal detection and therefore sensing performances of the ICM.
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| Measure | Description | Time Frame |
|---|---|---|
| R-wave amplitude | R-wave amplitude at 3-month Home Monitoring observation in patients with a BMI > 30 | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of 'noise burden' | Measurement of amount of 'noise burden' during the study period | 3 month |
| P-wave visibility | Measurement of the P-wave visibility at 1- and 3-month Home Monitoring observation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of arrhythmias | Assessment of the incidence of arrhythmias in obese patients implanted with an ICM | 3 month |
Inclusion Criteria:
Exclusion Criteria:
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The patient population consists of obese patients (BMI > 30 kg/m2) with an implantable cardiac monitor
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Bisignani, Dr. | Ospedale Civile Ferrari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Civile Ferrari | Castrovillari | 87012 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37025684 | Derived | Bisignani G, De Bonis S, Pierre B, Lau DH, Hofer D, Sanfins VM, Hain A, Cabanas P, Martens E, Berruezo A, Eschalier R, Milliez P, Lusebrink U, Mansourati J, Papaioannou G, Giacopelli D, Gargaro A, Ploux S. Insertable cardiac monitor with a long sensing vector: Impact of obesity on sensing quality and safety. Front Cardiovasc Med. 2023 Mar 21;10:1148052. doi: 10.3389/fcvm.2023.1148052. eCollection 2023. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D013575 | Syncope |
| D001919 | Bradycardia |
| D000083242 | Ischemic Stroke |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 1 month and 3 month |
| 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 |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |