CClinicalTrials.gg
Status unknownNCT04200014Updated Jan 10, 2020

Bradycardia Risk Stratification With Loop Recorder After Syncope

An observational study in Implantable Loop Recorder, sponsored by Central Hospital, Nancy, France. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2020-01-10.

Sponsored by Central Hospital, Nancy, France · Observational

The sponsor has not verified this record recently (last verified Dec 2019), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
250
Sex
All
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Study 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

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Conditions studied

  • Implantable Loop Recorder

Keywords

  • Syncope
  • Arrhythmia
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In context

Syncope

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

This study's planned enrollment of 250 is above the median of 221 across 91 observational studies indexed under Syncope.

Browse Syncope studies →

Lead sponsor

Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital between 1 January 2010 and 31 decembre 2019

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No Exclusion Criteria
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Syncope and Implantable loop recorder

    Patients implanted with a subcutaneous Loop Recorder after syncope in Nancy University Hospital

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What researchers measure

Primary outcomes

  1. significant bradycardia whitch result with an Indication of pacemaker implantation

    2° and 3° AV block, sinus node dysfunction with pause \> 8 sec or \> 3sec with concomitant symptoms, sick sinus syndrom

    Time frame: At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up

Secondary outcomes

  1. Patient group without benefit of implantation of the Implantable Loop Recorder

    non significant bradicardia or arythmias revealed by loop recorder during monitoring

    Time frame: At the end of the 3 years of follow-up

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available. PubMed 29562304 ↗
  • Edvardsson N, Wolff C, Tsintzos S, Rieger G, Linker NJ. Costs of unstructured investigation of unexplained syncope: insights from a micro-costing analysis of the observational PICTURE registry. Europace. 2015 Jul;17(7):1141-8. doi: 10.1093/europace/euu412. Epub 2015 Mar 10. PubMed 25759408 ↗
  • Padmanabhan D, Kancharla K, El-Harasis MA, Isath A, Makkar N, Noseworthy PA, Friedman PA, Cha YM, Kapa S. Diagnostic and therapeutic value of implantable loop recorder: A tertiary care center experience. Pacing Clin Electrophysiol. 2019 Jan;42(1):38-45. doi: 10.1111/pace.13533. Epub 2018 Dec 4. PubMed 30357866 ↗

Individual participant data

Plan to share: Yes — anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available

Supporting information: Sap, Icf, Csr

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2020, 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
NCT04200014
Lead sponsor
Central Hospital, Nancy, France
Responsible party
Sponsor
First posted
Dec 16, 2019
Start date
Dec 9, 2019
Primary completion
Jan 31, 2020 (estimated)
Completion
Mar 31, 2020 (estimated)
Last update
Jan 10, 2020

Study contacts

Guillaume E DE CIANCIO, MD
Contact
g.deciancio@gmail.com
0683050105
Arnaud OLIVIER, MD
Contact
a.olivier@chru-nancy.fr

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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