Implantable Loop Recorder in Traumatic Syncope (TRAUMA)

Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope

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.

Study Overview

• Status: Completed
• Conditions: Syncope
• Intervention / Treatment: Other: outpatient 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 Type: Observational
• Enrollment (Actual): 488

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• patients unable to attend scheduled outpatient visits

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Traumatic syncope recurrence	Incidence of traumatic syncope recurrence	through study completion, an average of 2 year

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Cardinale G. Panico
• Collaborators: University of Campania "Luigi Vanvitelli"; Università Politecnica delle Marche; Azienda Ospedaliero Universitaria Maggiore della Carita; Istituto Nazionale di Ricovero e Cura per Anziani; Azienda Ospedaliera Pugliese Ciaccio; Cardiology Department, Policlinico Riuniti University Hospital, Foggia, Italy; Cardiology Division, Villa Scassi Hospital, Genova ASL 3, Genova; San Giuseppe e Melorio Hospital, Santa Maria Capua Vetere; Nostra Signora di Bonaria Hospital, San Gavino Monreale

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: April 1, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 1, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Syncope
• Other Study ID Numbers: trauma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No