Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms

Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.

Actually, there are few data about the effectiveness of remote monitoring (RM) and patient centered alarms setting in patients with unexplained syncope underwent implanted loop recorder (ILR) monitoring.

The aim of this study is to evaluate the time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.

Study Overview

• Status: Recruiting
• Conditions: Syncope; Remote Monitoring; Loop Recorder
• Intervention / Treatment: Other: Remote Monitoring

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Vincenzo Russo
• Study Contact Backup: Name: Vincenzo Russo, MD PhD; Phone Number: 0817062355; Email: vincenzo.russo@unicampania.it

Study Locations

• Italy
  • Naples, Italy
    • Recruiting
    • University of Campania "Luigi Vanvitelli"
    • Contact: Vincenzo Russo; Email: vincenzo.russo@unicampania.it
    • Contact: Vincenzo Russo
    • Principal Investigator: Vincenzo Russo, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population included all patients with unexplained syncope underwent ICM implantation according to current gudelines and followed by conventionally or RM according to the hospital's clinical practice.

Description

Inclusion Criteria

• Patients with unexplained syncope underwent ICM implantation according to current gudelines.

Exclusion Criteria

• Patients do not provied signing Patient Informed Consent Form

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ILR Group followed with RM; Patients with unexplained syncope underwent ILR monitoring and followed with RM	Other: Remote Monitoring; Remote Monitoring Follow-up
ILR Group followed with in-hospital visits; Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to medical treatment	Time from onset of first physician's evaluation of asyntomatic ECG events lead to medical treatment in ordinary clinical practice for syncope patients with ILR patients and compare it between patients followed with RM or conventionally with annual in-hospital visits.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2020
• Primary Completion (Anticipated): March 16, 2022
• Study Completion (Anticipated): March 16, 2024

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Syncope; Remote Monitoring; Loop Recorder
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: 181060320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No