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

NCT ID: NCT05974306

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2027-06-01

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).

Conditions

Heart Failure; Arrhythmias, Cardiac

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ILR group

patients implanted with an implantable loop recorder to be monitored remotely.

Group Type: EXPERIMENTAL

implantable loop recorder

Intervention Type: DEVICE

Implantation of an implantable loop recorder

in-hospital fup group

Patients that will be followed with in-hospital visits.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

implantable loop recorder

Implantation of an implantable loop recorder

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leonardo Calò, MD

OTHER

Sponsor Role: lead

Responsible Party

Leonardo Calò, MD

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

v.2.0 29 mar23

Identifier Type: -

Identifier Source: org_study_id