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

N/ANot Yet RecruitingNCT05974306

Leonardo Calò, MD331 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

331

Conditions

Heart Failure Arrhythmias, Cardiac

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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)

Time frame: 2 years