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)
| Registry | NCT05974306, acronym VASCO |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 331 (Estimated) |
| Sponsor | Leonardo Calò, MD (Other) |
| Conditions | Heart Failure, Arrhythmias, Cardiac |
| Interventions | implantable loop recorder (Device) |
| Dates | start 2023-09-01 (estimated), primary completion 2024-06-01 (estimated), completion 2027-06-01 (estimated), first posted 2023-08-03, last updated 2023-08-03 |
Related Papers Related Patents Related Grants Related Experts
All trials for Heart Failure All trials for Arrhythmias, Cardiac All trials of implantable loop recorder
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ILR group | Experimental | Device: implantable loop recorder | patients implanted with an implantable loop recorder to be monitored remotely. |
| in-hospital fup group | No intervention | Patients that will be followed with in-hospital visits. |
Sex: All, ages: 18 Years to 100 Years
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)