Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Leonardo Calò, MD
Conditions:
Heart Failure
Arrhythmias, Cardiac
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT05974306
Start Date
September 1 2023
End Date
June 1 2027
Last Update
August 3 2023
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