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Vasco trial is a no profit, multicenter, international, prospective, randomized study designed to evaluate the clinical benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and left ventricle ejection fraction (LVEF)> 40% .The study will enroll about 331 patients (221 in the ILR group and 110 in the in-hospital follow-up group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILR group | Experimental | patients implanted with an implantable loop recorder to be monitored remotely. |
|
| in-hospital fup group | No Intervention | Patients that will be followed with in-hospital visits. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implantable loop recorder | Device | Implantation of an implantable loop recorder |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the benefits of a remote monitoring management based on ILR vs standard practice in patients with high risk of cardiac arrhythmias, heart failure and LVEF> 40% in the detection of significant clinical events. | Detection rate of arrhythmias that require treatment (medical or interventional) | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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