Implantable Loop Recorder in Traumatic Syncope

NCT ID: NCT04832542

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

488 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-01

Study Completion Date

2021-01-31

Brief Summary

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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

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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.

Conditions

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Syncope

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients unable to attend scheduled outpatient visits
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Politecnica delle Marche

OTHER

Sponsor Role collaborator

University of Campania Luigi Vanvitelli

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Pugliese Ciaccio

OTHER

Sponsor Role collaborator

Azienda Ospedaliero Universitaria Maggiore della Carita

OTHER

Sponsor Role collaborator

Cardiology Department, Policlinico Riuniti University Hospital, Foggia, Italy

UNKNOWN

Sponsor Role collaborator

Cardiology Division, Villa Scassi Hospital, Genova ASL 3, Genova

UNKNOWN

Sponsor Role collaborator

San Giuseppe e Melorio Hospital, Santa Maria Capua Vetere

UNKNOWN

Sponsor Role collaborator

Nostra Signora di Bonaria Hospital, San Gavino Monreale

UNKNOWN

Sponsor Role collaborator

Istituto Nazionale di Ricovero e Cura per Anziani

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Cardinale G. Panico

OTHER

Sponsor Role lead

Responsible Party

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Pietro Palmisano

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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TRAUMA

Identifier Type: -

Identifier Source: org_study_id

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