Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System

Study Overview
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Brief Summary
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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).

Official Title
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Evaluation of a Proactive Clinical Management and Early Diagnosis of Arrhythmias in Patients With Heart Failure and Non Severely Reduced Left Ventricular Function Through a Telemonitoring System: a Prospective Randomized Clinical Trial (VASCO)

Conditions
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Heart Failure, Arrhythmias, Cardiac

Intervention / Treatment
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* Device: implantable loop recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with heart failure, LVEF> 40% who report episodes of palpitations. Over 18 years of age Ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations Exclusion Criteria: Subject who is, or is expected to be unavailable for follow-up Pregnancy Medical contraindications for ILR implantation Patients with PMK / ICD or with Indication for ICD / PMK implantation Cardiovascular events / myocardial revascularization in the previous three months Patients already on oral anticoagulant treatment Patients who do not want to use the telemonitoring system Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic stroke/TIA, Transient loss of consciousness and recurrent falls)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ILR group<br>patients implanted with an implantable loop recorder to be monitored remotely. | Device: implantable loop recorder<br>* Implantation of an implantable loop recorder<br>|
| No Intervention: in-hospital fup group<br>Patients that will be followed with in-hospital visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |