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This study will evaluate safety and clinical outcomes of a systematic defibrillation threshold testing in patient with indication for defibrillator replacement.
Implantable cardioverter defibrillators (ICD) are strongly recommended in patients with left ventricular systolic function ≤35% or selected patients with channelopathies and cardiomyopathies.
Defibrillation threshold testing (DFT) defines the minimal energy required to successfully terminate a ventricular arrhythmia by an ICD. It remains the gold standard to evaluate the electrical integrity of the device. However inherent complications of this procedure have been registered, such as refractory ventricular fibrillation, and the need for this practice during implant and/or replacement of ICD has recently been questioned.
If several studies have led to abandonment of the DFT during initial ICD implant, its interest during replacement is still controversial. Indeed, the leads essential for the device electrical integrity are older, more fragile, and the ICD replacement may damage it.
Device replacement is indicated when battery reaches the point of Elective Replacement Interval (ERI).
Patients over 18 years old with indication for replacement of defibrillator will be included. Patient's informations (comorbidities, medical history and events during hospitalization or follow-up) and device characteristics will be collected. Procedure will be realized under local or general anesthesia and prophylactic antibiotic will be administrated. Leads will be tested before and after the implantation of the new device. After connexion of the new implanted device to the leads a DFT will be performed. Protocol of DFT will be decided by the physician who will chose between induction of ventricular fibrillation or R-wave synchronized shock. Patients will be followed for 6 and 12 months from the date of defibrillator replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defibrillation testing during ICD replacment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrillator threshold testing | Diagnostic Test | Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. | Number of Participants With Abnormal Shock Impedance Value. | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Lead Malfunction | Number of Participants With Abnormal Shock Impedance Value. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Trousseau | Chambray-lès-Tours | Centre-Val de Loire | 37170 | France | ||
| Institut Lorrain du Coeur et des Vaisseaux Louis Mathieu-CHU de Nancy-Hôpitaux de Brabois |
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| ID | Title | Description |
|---|---|---|
| FG000 | Defibrillation Testing During ICD Replacment | Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Procedure |
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| |||||||||||||||||||||
| 12-Month Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Defibrillation Testing During ICD Replacment | Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Rate of Defibrillator Electrical Integrity Dysfunction During Generator Replacement. | Number of Participants With Abnormal Shock Impedance Value. | Posted | Count of Participants | Participants | 4 hours |
|
|
from enrollment until end of follow-up (12-months follow-up)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Defibrillation Testing During ICD Replacment | Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caroline GRIMARD | CMC Ambroise Paré Hartmann | 0146413126 | recherche@clinique-a-pare.fr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 28, 2020 | Apr 22, 2026 | Prot_SAP_000.pdf |
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| Vandœuvre-lès-Nancy |
| Grand Est |
| 54500 |
| France |
| CHU de Caen | Caen | Normandy | 14000 | France |
| CHU de Toulouse-Hôpital Rangueil | Toulouse | Occitanie | 31400 | France |
| Hôpital Privé du Confluent | Nantes | Pays de la Loire Region | 44277 | France |
| Centre Hospitalier Henri Duffaut | Avignon | Provence-Alpes-Côte d'Azur Region | 84902 | France |
| CMC Ambroise Paré | Neuilly-sur-Seine | Île-de-France Region | 92200 | France |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m2 |
|
|
| Secondary | Rate of Lead Malfunction | Number of Participants With Abnormal Shock Impedance Value. | Posted | Count of Participants | Participants | 12 months |
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|
| 0 |
| 143 |
| 0 |
| 143 |
| 0 |
| 143 |
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