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

NCT05974306 | Not Yet Recruiting

• 1 other identifier: v.2.0 29 mar23
• Study Type: interventional
• Target: 331
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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)

  2 years

Study Arms (2)

ILR group

EXPERIMENTAL

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

Device: implantable loop recorder

in-hospital fup group

NO INTERVENTION

Patients that will be followed with in-hospital visits.

Interventions

implantable loop recorder DEVICE

Implantation of an implantable loop recorder

ILR group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Leonardo Calò, MD: lead

MeSH Terms

Conditions

Heart Failure; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: August 3, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share