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

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

Study Overview

• Status: Unknown
• Conditions: Implantable Loop Recorder

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Guillaume E DE CIANCIO, MD; Phone Number: 0683050105; Email: g.deciancio@gmail.com
• Study Contact Backup: Name: Arnaud OLIVIER, MD; Email: a.olivier@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • De Ciancio
    • Contact: Arnaud OLIVIER, MD; Email: a.olivier@chru-nancy.fr
    • Contact: Guillaume E DE CIANCIO; Phone Number: 0683050105; Email: g.deciancio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No Exclusion Criteria

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Syncope and Implantable loop recorder; Patients implanted with a subcutaneous Loop Recorder after syncope in Nancy University Hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient group without benefit of implantation of the Implantable Loop Recorder	non significant bradicardia or arythmias revealed by loop recorder during monitoring	At the end of the 3 years of follow-up

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2019
• Primary Completion (Anticipated): January 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: December 13, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): January 10, 2020
• Last Update Submitted That Met QC Criteria: January 7, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Arrhythmia; Syncope
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Arrhythmias, Cardiac; Unconsciousness; Consciousness Disorders; Bradycardia; Syncope
• Other Study ID Numbers: 2019PI198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available
• IPD Sharing Time Frame: 6 month
• IPD Sharing Access Criteria: Data access request will be reviewed by investigator team. Requestors will be required to signe a data access agreement
• IPD Sharing Supporting Information Type: SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No