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

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)

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05974306

Acronym

VASCO

Enrollment

331

Registered

2023-08-03

Start date

2023-09-01

Completion date

2027-06-01

Last updated

2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac, Heart Failure

Brief summary

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).

Interventions

DEVICEimplantable loop recorder

Implantation of an implantable loop recorder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
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.	2 years	Detection rate of arrhythmias that require treatment (medical or interventional)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026