Implantable Loop Recorder in Traumatic Syncope

Completed

• Conditions: Syncope

• Registration Number: NCT04832542
• Lead Sponsor: Azienda Ospedaliera Cardinale G. Panico

Brief Summary

Prospective, observational registry enrolling consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation with the aim to evaluate the incidence of recurrence of traumatic syncope during follow-up.

Detailed Description

This observational, prospective registry enrolled consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation according to current clinical practice. The patients were evaluated every 6 months based on current clinical practice and the risk of recurrence of traumatic syncope was assessed during follow-up.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-01-31
• Status Verified: 2021-04
• Study First Submitted: 2021-04-01
• Study First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

• patients with recurrent, unexplained, traumatic syncope
• patients underwent implantable loop recorder implantation

Exclusion Criteria

• patients unable to attend scheduled outpatient visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Traumatic syncope recurrence	through study completion, an average of 2 year	Incidence of traumatic syncope recurrence