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Bradycardia Risk Stratification With Loop Recorder After Syncope

Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04200014
Enrollment
250
Registered
2019-12-16
Start date
2019-12-09
Completion date
2020-03-31
Last updated
2020-01-10

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

Conditions

Implantable Loop Recorder

Keywords

Syncope, Arrhythmia

Brief summary

Syncope is a common symptom that may be related to a conductive disorder. If no bradycardia is authenticated, it is often necessary to implant an implantable loop recorder. In somes cases, implantable loop recorder records cardiac conductive disorders. In this study, we want to try to identify a group of patients for whom we could immediately implant a pacemaker without prior implantation of an implantable loop recorder given the high probability of implantation of a pacemaker after interrogation of the implantable loop recorder. It would be interesting for the reduction of interventions for the patients and for the economic aspect of the healthcare system

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital

Exclusion criteria

* No

Design outcomes

Primary

MeasureTime frameDescription
significant bradycardia whitch result with an Indication of pacemaker implantationAt the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up2° and 3° AV block, sinus node dysfunction with pause \> 8 sec or \> 3sec with concomitant symptoms, sick sinus syndrom

Secondary

MeasureTime frameDescription
Patient group without benefit of implantation of the Implantable Loop RecorderAt the end of the 3 years of follow-upnon significant bradicardia or arythmias revealed by loop recorder during monitoring

Countries

France

Contacts

Primary ContactGuillaume E DE CIANCIO, MD
g.deciancio@gmail.com0683050105
Backup ContactArnaud OLIVIER, MD
a.olivier@chru-nancy.fr

Outcome results

None listed

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