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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 331
Last updated 2023-08-03
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
Interventions
- DEVICE
-
implantable loop recorder
Implantation of an implantable loop recorder
Sponsors & Collaborators
-
Leonardo Calò, MD
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-01
- Primary Completion
- 2024-06-01
- Completion
- 2027-06-01
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