Implantable Loop Recorder in Traumatic Syncope
TRAUMA
Safety and Effectiveness of Implantable Loop Recorder in Patients With Recurrent, Unexplained, Traumatic Syncope
1 other identifier
observational
488
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2011
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2021
CompletedFirst Submitted
Initial submission to the registry
April 1, 2021
CompletedFirst Posted
Study publicly available on registry
April 6, 2021
CompletedApril 6, 2021
April 1, 2021
10 years
April 1, 2021
April 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Traumatic syncope recurrence
Incidence of traumatic syncope recurrence
through study completion, an average of 2 year
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.
Eligibility Criteria
Consecutive patients with recurrent, unexplained, traumatic syncope underwent implantable loop recorder implantation
You may qualify if:
- patients with recurrent, unexplained, traumatic syncope
- patients underwent implantable loop recorder implantation
You may not qualify if:
- patients unable to attend scheduled outpatient visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azienda Ospedaliera Cardinale G. Panicolead
- Università Politecnica delle Marchecollaborator
- University of Campania Luigi Vanvitellicollaborator
- Azienda Ospedaliera Pugliese Ciacciocollaborator
- Azienda Ospedaliero Universitaria Maggiore della Caritacollaborator
- Cardiology Department, Policlinico Riuniti University Hospital, Foggia, Italycollaborator
- Cardiology Division, Villa Scassi Hospital, Genova ASL 3, Genovacollaborator
- San Giuseppe e Melorio Hospital, Santa Maria Capua Veterecollaborator
- Nostra Signora di Bonaria Hospital, San Gavino Monrealecollaborator
- Istituto Nazionale di Ricovero e Cura per Anzianicollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 1, 2021
First Posted
April 6, 2021
Study Start
January 1, 2011
Primary Completion
December 31, 2020
Study Completion
January 31, 2021
Last Updated
April 6, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share