Back to resultsEvaluation 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 (VASCO)
Primary Purpose
Heart Failure, Arrhythmias, Cardiac
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
implantable loop recorder
Sponsored by
About this trial
This is an interventional diagnostic trial for Heart Failure
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
ILR group
in-hospital fup group
Arm Description
patients implanted with an implantable loop recorder to be monitored remotely.
Patients that will be followed with in-hospital visits.
Outcomes
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.
Detection rate of arrhythmias that require treatment (medical or interventional)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05974306
Brief 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
Acronym
VASCO
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Leonardo Calò, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Arrhythmias, Cardiac
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
331 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ILR group
Arm Type
Experimental
Arm Description
patients implanted with an implantable loop recorder to be monitored remotely.
Arm Title
in-hospital fup group
Arm Type
No Intervention
Arm Description
Patients that will be followed with in-hospital visits.
Intervention Type
Device
Intervention Name(s)
implantable loop recorder
Intervention Description
Implantation of an implantable loop recorder
Primary Outcome Measure Information:
Title
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.
Description
Detection rate of arrhythmias that require treatment (medical or interventional)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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)
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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
We'll reach out to this number within 24 hrs