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Implantable Loop Recorder in Traumatic Syncope

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04832542
Acronym
TRAUMA
Enrollment
488
Registered
2021-04-06
Start date
2011-01-01
Completion date
2021-01-31
Last updated
2021-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

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.

Interventions

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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* patients unable to attend scheduled outpatient visits

Design outcomes

Primary

MeasureTime frameDescription
Traumatic syncope recurrencethrough study completion, an average of 2 yearIncidence of traumatic syncope recurrence

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026