Implantable Loop RecorderNCT04200014
Bradycardia Risk Stratification With Loop Recorder After Syncope
An observational study of Implantable Loop Recorder, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implantable Loop Recorder
- Type of treatment
- Injection or infusion
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital
Who cannot join
- No Exclusion Criteria
Trial locations and contacts
1 site in 1 country.
Arnaud OLIVIER, MD contact
France1 site, 1 recruiting
- Recruiting
De Ciancio
Vandœuvre-lès-Nancy, 54500
Guillaume E DE CIANCIO, 0683050105, g.deciancio@gmail.com
Arnaud OLIVIER, MD, a.olivier@chru-nancy.fr
About this study
Official title: 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
- Conditions
- Implantable Loop Recorder
- Keywords
- Syncope, Arrhythmia
- Medical subject headings
- Syncope, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Syncope and Implantable loop recorder | Patients implanted with a subcutaneous Loop Recorder after syncope in Nancy University Hospital |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: At the end of the 3 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start9 Dec 2019
- Primary completion31 Jan 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Implantable Loop RecorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200014
- Sponsor's protocol ID
- 2019PI198
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 10 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available
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 29562304Edvardsson 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 25759408Padmanabhan 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bradycardia High Risk Patient Identification After Syncope With Loop Recorder an Observational Study in Nancy University Hospital
- ClinicalTrials.gov ID
- NCT04200014
- Acronym / sponsor ID
- 2019PI198
- Conditions
- Implantable Loop Recorder
- Keywords
- Syncope, Arrhythmia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 31 Jan 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syncope and Implantable loop recorder | – | –Patients implanted with a subcutaneous Loop Recorder after syncope in Nancy University Hospital |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who have benefited from an Implantable Loop recorder in the Nancy's Teaching Hospital
Key exclusion criteria (1 listed)
- No Exclusion Criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
significant bradycardia whitch result with an Indication of pacemaker implantation
Time frame: At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up
2° and 3° AV block, sinus node dysfunction with pause > 8 sec or > 3sec with concomitant symptoms, sick sinus syndrom
1 secondary outcome
Patient group without benefit of implantation of the Implantable Loop Recorder
Time frame: At the end of the 3 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2020.
- Background: PubMed 29562304Brignole 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.
- Background: PubMed 25759408Edvardsson 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.
- Background: PubMed 30357866Padmanabhan 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.
- Individual participant dataSharing planned: Yes. anonymous individual datas for baseling pre implantatory caracteristcs and clinical outecome would be available
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud OLIVIER, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Implantable Loop Recorder, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guillaume E DE CIANCIO, MD (0683050105, g.deciancio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
significant bradycardia whitch result with an Indication of pacemaker implantation (time frame: At the moment of enregistrement of a significative arrhythmia or at the end of the 3 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04200014, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2020; AzTrials last refreshed its copy on 27 Oct 2026.