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The objective of this study is to demonstrate the efficacy of the ENDOTAK® RELIANCE™ defibrillation leads connected to a defibrillator or a cardiac resynchronization defibrillator from implant until 12 months.
Baseline and clinical data were collected at inclusion, as were data on procedural characteristics, device implantation-related adverse events and device programming at the time of hospital discharge. Patients were subsequently divided in two groups: patients who underwent VF induction at implantation or before hospital discharge(VF induction group); and patients who did not undergo VF induction (untested group).The patients were followed up at 3-6 months and at12 months after the implantation. VF induction procedures were left to the investigator's discretion, but reasons for not performing a VF induction at implantation were recorded prospectively. ICD programming parameters for tachycardia or bradycardia were also left at the investigator's discretion.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endotak Reliance | Device | Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Defibrillation testing (DT) procedures and consequences on clinical outcomes | to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during implantation | at implant |
| Defibrillation testing (DT) procedures and consequences on clinical outcomes | to determine the DT procedures used in everyday practice, to compare the characteristics of patients with or without DTand to compare severe adverse events in these two populations during 1 year follow-up | during 1 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive patients with the indication for an implantable ICD are invited to participate.
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Sadoul, MD | CHU Brabois, Nancy | Principal Investigator |
| Arnaud Lazarus, MD | Clinique Bizet, Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Amiens | Amiens | 80054 | France | |||
| CHU Angers |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Angers |
| 49033 |
| France |
| Hôpital Angoulème | Angoulème | 16470 | France |
| Clinique Cardiologique Aressy | Aressy | 64320 | France |
| CH Avignon | Avignon | 84902 | France |
| CHU du Morvan | Brest | 29609 | France |
| Hôpital Côte de Nacre | Caen | 14033 | France |
| CHU Henri Mondor | Créteil | 94000 | France |
| CHU Michalon | Grenoble | 38043 | France |
| CH Hôpital Nord | Marseille | 13008 | France |
| CHU La Timone | Marseille | 13385 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU Brabois | Nancy | France |
| Nouvelle Clinique Nantaise | Nantes | 44000 | France |
| CHU Nantes | Nantes | 44295 | France |
| CHU Nice | Nice | 06002 | France |
| CHU D'Orleans | Orléans | 45000 | France |
| Clinique Bizet | Paris | France |
| CHG Pau | Pau | 64046 | France |
| CHU Pontchaillou | Rennes | 35033 | France |
| CHU Rouen | Rouen | 76031 | France |
| Centre cardiologique du Nord | Saint-Denis | 93000 | France |
| CMC Arnaud Tzanck | Saint-Laurent-du-Var | 6700 | France |
| CHU Rangueil | Toulouse | 31403 | France |
| Clinique St. Gatien | Tours | 37000 | France |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |