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Completed

NCT Number: NCT04832542

Implantable Loop Recorder in 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.

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Key information

Conditions

Syncope Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • patients unable to attend scheduled outpatient visits

Treatment and study plan

outpatient follow-up

Other

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.

Primary outcomes

  1. Traumatic syncope recurrence

    Time frame: through study completion, an average of 2 year

    Incidence of traumatic syncope recurrence

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico

Other

Collaborators

  • 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
  • University of Campania Luigi Vanvitelli
  • Università Politecnica delle Marche

Registry information

Official study title

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

Acronym: TRAUMA

Important dates

Study start
2011
Primary completion
2020
Study completion
2021
First posted
Apr 6, 2021
Registry last updated
Apr 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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