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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05974306
Other study ID # v.2.0 29 mar23
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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