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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: implantable loop recorder.
- Who it may be relevant to
- Registry conditions: Heart Failure, Arrhythmias, Cardiac. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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).
Interventions
- Device implantable loop recorder
Implantation of an implantable loop recorder
Primary outcome measures
- 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. [Time frame: 2 years]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05974306 · v.2.0 29 mar23