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

• Conditions: Loop Recorder; Syncope; Remote Monitoring

• Registration Number: NCT04435262
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-10
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17
• Primary Completion: 2022-03-16
• Study Completion: 2024-03-16

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to medical treatment	through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

University of Campania "Luigi Vanvitelli"; 🇮🇹 Naples, Italy