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

Heart Failure Clinical Trial

— VASCO  

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05974306
• Other study ID #: v.2.0 29 mar23
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: August 2023
• Source: Policlinico Casilino ASL RMB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 331
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Heart Failure

Intervention

Device:
• implantable loop recorder
Implantation of an implantable loop recorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Leonardo Calò, MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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