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VASCO: 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

Sponsor
Leonardo Calò, MD (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05974306
Collaborator
(none)
331
Enrollment
2
Arms
45
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Device: implantable loop recorder
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
331 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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)
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: ILR group

patients implanted with an implantable loop recorder to be monitored remotely.

Device: implantable loop recorder
Implantation of an implantable loop recorder
No Intervention: in-hospital fup group

Patients that will be followed with in-hospital visits.

Outcome Measures

Primary Outcome Measures

  1. 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. [2 years]

    Detection rate of arrhythmias that require treatment (medical or interventional)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Leonardo Calò, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Leonardo Calò, MD, Principal Investigator, Policlinico Casilino ASL RMB
ClinicalTrials.gov Identifier:
NCT05974306
Other Study ID Numbers:
  • v.2.0 29 mar23
First Posted:
Aug 3, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Heart Failure
Arrhythmias, Cardiac

Study Results

No Results Posted as of Aug 3, 2023