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 (VASCO)

Leonardo Calò, MD

Status

Not yet enrolling

Conditions

Arrhythmias, Cardiac

Heart Failure

Treatments

Device: implantable loop recorder

Study type

Interventional

Funder types

Other

Identifiers

NCT05974306

v.2.0 29 mar23

Details and patient eligibility

About

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).

Enrollment

331 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)