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

University of Campania "Luigi Vanvitelli"

Status: Enrolling

Conditions: Syncope; Remote Monitoring; Loop Recorder

Treatments: Other: Remote Monitoring

Study type: Observational

Funder types: Other

Identifiers

NCT04435262

181060320

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

• Patients do not provied signing Patient Informed Consent Form

Trial design

200 participants in 2 patient groups

ILR Group followed with RM

Description:

Patients with unexplained syncope underwent ILR monitoring and followed with RM

Treatment:

Other: Remote Monitoring

ILR Group followed with in-hospital visits

Description:

Patients with unexplained syncope underwent ILR monitoring and followed with in-hospital visits