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

Syncope Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04435262
• Other study ID #: 181060320
• Status: Recruiting
• Start date: May 10, 2020
• Est. completion date: March 16, 2024

Study information

• Verified date: August 2021
• Source: University of Campania "Luigi Vanvitelli"
• Contact: Vincenzo Russo, MD PhD
• Phone: 0817062355
• Email: vincenzo.russo[@]unicampania.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 16, 2024
• Est. primary completion date: March 16, 2022
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria

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

Exclusion Criteria

• Patients do not provied signing Patient Informed Consent Form

Related Conditions & MeSH terms

• Loop Recorder
• Remote Monitoring
• Syncope

Intervention

Other:
• Remote Monitoring
Remote Monitoring Follow-up

Locations

Country	Name	City	State
Italy	University of Campania "Luigi Vanvitelli"	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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