Implantable Loop Recorder Clinical Trial
Official title:
Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital
| NCT number | NCT04200014 |
| Other study ID # | 2019PI198 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | December 9, 2019 |
| Est. completion date | March 31, 2020 |
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
| Status | Recruiting |
| Enrollment | 250 |
| Est. completion date | March 31, 2020 |
| Est. primary completion date | January 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital Exclusion Criteria: - No Exclusion Criteria |
| Country | Name | City | State |
|---|---|---|---|
| France | De Ciancio | Vandœuvre-lès-Nancy |
| Lead Sponsor | Collaborator |
|---|---|
| Central Hospital, Nancy, France |
France,
Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martín 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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |