NCT05974306Not 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
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)
Source: ClinicalTrials.gov · Last updated 3 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 331 (estimated)
- First submitted
- 14 Jun 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Leonardo Calò, MD
- Diseases
- Heart failure
- NCT number
- NCT05974306
What you commit to
- Study type: Interventional
- Planned participants: 331
- From 1 Sept 2023 to the primary completion date, 1 Jun 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiovascular events / myocardial revascularization in the previous three months
Other illness
- Presence of other recognized indications to ILR (Unexplained syncope, cryptogenic stroke/TIA, Transient loss of consciousness and recurrent falls)
Other
- 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
- Patients already on oral anticoagulant treatment
- Patients who do not want to use the telemonitoring system
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.