Implantable Loop Recorder in Traumatic Syncope

Syncope Clinical Trial

— TRAUMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04832542
• Other study ID #: TRAUMA
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: January 31, 2021

Study information

• Verified date: April 2021
• Source: Azienda Ospedaliera Cardinale G. Panico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with recurrent, unexplained, traumatic syncope

• patients underwent implantable loop recorder implantation

Exclusion Criteria:

• patients unable to attend scheduled outpatient visits

Related Conditions & MeSH terms

• Syncope

Intervention

Other:
• outpatient follow-up
The patients were evaluated every six months in order to assess the incidence of traumatic syncope recurrence during follow-up after implantable loop recorder implantation.

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor

Collaborator

Azienda Ospedaliera Cardinale G. Panico

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traumatic syncope recurrence	Incidence of traumatic syncope recurrence	through study completion, an average of 2 year