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The purpose of this study is to use implantable loop recorder (ILR) in patients under chronic hemodialysis to record arrhythmias and conduction disorders and correlate them with hemodialysis parameters.
Primary cause of death in patients under chronic hemodialysis is Sudden Cardiac Death (SCD) (25% of all cause mortality). SCD is mainly due to cardiac arrhythmias (conduction disturbances or ventricular arrhythmias). These cardiac arrhythmias are highly sensitive to hydro-electrolytic disorders which are extremely frequent in patients under hemodialysis. In addition, other conditions leading to cardiac arrhythmias are frequent in this population such as ischemic myocardiopathy or dilated myocardiopathy. However, so far, little is known about the occurrence of arrhythmias because of studies using only standard Holter monitoring (24 to 48 hours monitoring at best).
The investigators sought to evaluate the incidence of cardiac arrhythmias by using an implantable loop recorder (ILR)(Reveal XT, Medtronic) that allows continuous rhythm monitoring for 24 months. This ILR will be implanted under local anesthesia.
Clinical follow-up will be performed during hemodialysis and rhythm management will be performed automatically using a remote-monitoring system (Carelink, Medtronic). Pre-programmed alerts (conduction disturbances, supra-ventricular arrhythmias or ventricular arrhythmias) recorded by the ILR will be sent automatically on a daily basis in our center. These data will be analyzed during week days from 9AM to 5PM. They will be reviewed by an electrophysiologists and depending on the potential lethality, the patients will be called and ask to come to the emergency room in case of high risk or the nephrologist will be contacted and he will see the patients during the next hemodialysis in case of on vital event.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantable loop recorder (ILR) in hemodialysis patients | Experimental | implantation of loop recorder in hemodialysis patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation of ILR | Device | Subcutaneous implantation of ILR under local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of arrhythmia |
| Checked every days except Sundays and bank holidays during 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Study correlation between arrhythmic events (primary outcome) and hemodialysis parameters (general: day of dialysis, length of dialysis;clinical: weight variation during dialysis...; biological: potassium level, potassium variation...; ECG) | three times per weeks, at each hemodialysis | |
| Incidence of supra-ventricular arrhythmia: 3A-Atrial Fibrillation, 3B-Atrial Tachycardia, 3C-Junctional tachycardia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian COMBE, MD-PhD | University Hospital of Bordeaux, France | Study Chair |
| Antoine BENARD, MD | USMR, University Hospital of Bordeaux, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Augustin | Bordeaux | 33074 | France | |||
| University Hospital of Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30089568 | Derived | Sacher F, Jesel L, Borni-Duval C, De Precigout V, Lavainne F, Bourdenx JP, Haddj-Elmrabet A, Seigneuric B, Keller A, Ott J, Savel H, Delmas Y, Bazin-Kara D, Klotz N, Ploux S, Buffler S, Ritter P, Rondeau V, Bordachar P, Martin C, Deplagne A, Reuter S, Haissaguerre M, Gourraud JB, Vigneau C, Mabo P, Maury P, Hannedouche T, Benard A, Combe C. Cardiac Rhythm Disturbances in Hemodialysis Patients: Early Detection Using an Implantable Loop Recorder and Correlation With Biological and Dialysis Parameters. JACC Clin Electrophysiol. 2018 Mar;4(3):397-408. doi: 10.1016/j.jacep.2017.08.002. Epub 2017 Sep 27. |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D003643 | Death |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Checked every days except Sundays and bank holidays during 24 Month |
| Bordeaux |
| 33076 |
| France |
| Polyclinique Bordeaux-Nord Aquitaine | Bordeaux | 33077 | France |
| CH de Haguenau | Haguenau | France |
| CH de Libourne | Libourne | France |
| CHU de Nantes | Nantes | 44093 | France |
| CHU de Rennes | Rennes | 35033 | France |
| CHU de Strasbourg | Strasbourg | 67091 | France |
| CHU de Toulouse | Toulouse | France |