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CompletedNCT04832542TRAUMAUpdated Apr 6, 2021

Implantable Loop Recorder in Traumatic Syncope

An observational study in Syncope, sponsored by Azienda Ospedaliera Cardinale G. Panico. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-06.

Sponsored by Azienda Ospedaliera Cardinale G. Panico · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
488
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Syncope

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03

In context

Syncope

232 studies on the registry are indexed under Syncope; 45 are open to participants now.

This study's enrollment of 488 is above the median of 235 across 95 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Azienda Ospedaliera Cardinale G. Panico is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients unable to attend scheduled outpatient visits
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
488 participants (actual)
Target follow-up
24 Months
Patient registry
Yes

Interventions

  • Otheroutpatient 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.

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What researchers measure

Primary outcomes

  1. Traumatic syncope recurrence

    Incidence of traumatic syncope recurrence

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2011 to primary completion in Dec 2020, 119 months.

Of 51 observational studies under Syncope, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 13. This study's 119 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2021
First posted
Apr 6, 2021
StartActual
Jan 1, 2011
Primary completionActual
Dec 31, 2020
CompletionActual
Jan 31, 2021
Last update
Apr 6, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 6, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04832542
Lead sponsor
Azienda Ospedaliera Cardinale G. Panico
Collaborators
Università Politecnica delle Marche, University of Campania Luigi Vanvitelli, 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, San Giuseppe e Melorio Hospital, Santa Maria Capua Vetere, Nostra Signora di Bonaria Hospital, San Gavino Monreale, Istituto Nazionale di Ricovero e Cura per Anziani
Responsible party
Pietro Palmisano (MD, Azienda Ospedaliera Cardinale G. Panico) — Principal investigator
First posted
Apr 6, 2021
Start date
Jan 1, 2011
Primary completion
Dec 31, 2020
Completion
Jan 31, 2021
Last update
Apr 6, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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