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

Not Applicable

Not yet recruiting

• Conditions: Heart Failure; Arrhythmias, Cardiac
• Interventions: Device: implantable loop recorder

• Registration Number: NCT05974306
• Lead Sponsor: Leonardo Calò, MD

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-14
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-02
• Last Update Submitted: 2023-08-02
• Study First Posted: 2023-08-03
• Last Update Posted: 2023-08-03
• Study Start: 2023-09-01
• Primary Completion: 2024-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 331

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ILR group	implantable loop recorder	patients implanted with an implantable loop recorder to be monitored remotely.

Primary Outcome Measures

Name	Time	Method
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)