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 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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Key information

Conditions

Heart Failure Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Implantable Loop Recorder

Device

Implantation of an implantable loop recorder

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.

Time frame: 2 years

Detection rate of arrhythmias that require treatment (medical or interventional)

Sponsors and collaborators

Lead sponsor

Leonardo Calò, MD

Other

Registry information

Official study title

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)

Acronym: VASCO

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2027
First posted: Aug 3, 2023
Registry last updated: Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed