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

• Sponsor: University of Campania "Luigi Vanvitelli" (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04435262
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 46.2
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Syncope; Loop Recorder; Remote Monitoring	Other: Remote Monitoring

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Syncope and Implanted Loop Recorder: the Utility of Remote Monitoring and Patients Centered Setting Alarms in Real World Setting.
• Actual Study Start Date: May 10, 2020
• Anticipated Primary Completion Date: Mar 16, 2022
• Anticipated Study Completion Date: Mar 16, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria

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

Exclusion Criteria

• Patients do not provied signing Patient Informed Consent Form

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Campania "Luigi Vanvitelli"	Naples		Italy

Sponsors and Collaborators

• University of Campania "Luigi Vanvitelli"

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vincenzo Russo, Principal Investigator, University of Campania "Luigi Vanvitelli"
• ClinicalTrials.gov Identifier: NCT04435262
• Other Study ID Numbers: 181060320
• First Posted: Jun 17, 2020
• Last Update Posted: Aug 17, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Vincenzo Russo, Principal Investigator, University of Campania "Luigi Vanvitelli": Syncope; Loop Recorder; Remote Monitoring
• Additional relevant MeSH terms: Syncope

Study Results

No Results Posted as of Aug 17, 2021