Leader - Evaluation of Endotak Reliance
This study has been completed.
Sponsor:
Guidant Corporation
Information provided by:
Guidant Corporation
ClinicalTrials.gov Identifier:
NCT00180349
First received: September 12, 2005
Last updated: June 3, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Ventricular Tachycardia Ventricular Fibrillation |
Device: Endotak Reliance |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Short and Long Term Evaluation of Electrical Measurements and Defibrillation Energies, Results of ATP and Diagnostic Functions of Devices Connected to Endotak RELIANCE® Defibrillation Leads |
Resource links provided by NLM:
Further study details as provided by Guidant Corporation:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Consecutive patients with the indication for an implantable ICD are invited to participate.
Criteria
Inclusion Criteria:
- ICD indication according to current guidelines with or without cardiac resynchronization therapy, being implanted with a Guidant ENDOTAK RELIANCE defibrillation lead as first implant, age above 18 years, able to understand the nature of the study and to be available for all follow-ups, having given consent in writing for anonymous data collection, life expectancy > 1 year.
Exclusion Criteria:
- device replacement without concomitant implant of a Reliance defibrillation lead, pregnancy or of birth bearing age without contraception, participation in another clinical study, short life expectancy due to other medical conditions, not willing to sign the consent form, geographically unstable for a defibrillator follow-up as required per protocol, having a ventricular arrhythmia, that can be treated by drugs or surgery
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00180349
Locations
| France | |
| CH Amiens | |
| Amiens, France, 80054 | |
| CHU Angers | |
| Angers, France, 49033 | |
| Hôpital Angoulème | |
| Angoulème, France, 16470 | |
| Clinique Cardiologique Aressy | |
| Aressy, France, 64320 | |
| CH Avignon | |
| Avignon, France, 84902 | |
| CHU du Morvan | |
| Brest, France, 29609 | |
| Hôpital Côte de Nacre | |
| Caen, France, 14033 | |
| CHU Henri Mondor | |
| Créteil, France, 94000 | |
| CHU Michalon | |
| Grenoble, France, 38043 | |
| CHU La Timone | |
| Marseille, France, 13385 | |
| CH Hôpital Nord | |
| Marseille, France, 13008 | |
| CHU Montpellier | |
| Montpellier, France, 34295 | |
| CHU Brabois | |
| Nancy, France | |
| CHU Nantes | |
| Nantes, France, 44295 | |
| Nouvelle Clinique Nantaise | |
| Nantes, France, 44000 | |
| CHU Nice | |
| Nice, France, 06002 | |
| CHU D'Orleans | |
| Orleans, France, 45000 | |
| Clinique Bizet | |
| Paris, France | |
| CHG Pau | |
| Pau, France, 64046 | |
| CHU Pontchaillou | |
| Rennes, France, 35033 | |
| CHU Rouen | |
| Rouen, France, 76031 | |
| Centre cardiologique du Nord | |
| St. Denis, France, 93000 | |
| CMC Arnaud Tzanck | |
| St. Laurent du Var, France, 6700 | |
| CHU Rangueil | |
| Toulouse, France, 31403 | |
| Clinique St. Gatien | |
| Tours, France, 37000 | |
Sponsors and Collaborators
Guidant Corporation
Investigators
| Principal Investigator: | Nicolas Sadoul, MD | CHU Brabois, Nancy |
| Principal Investigator: | Arnaud Lazarus, MD | Clinique Bizet, Paris |
More Information
No publications provided
| Responsible Party: | Elisabeth Mouton, Guidant France |
| ClinicalTrials.gov Identifier: | NCT00180349 History of Changes |
| Other Study ID Numbers: | Leader v. 1.0 10/04 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 3, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Tachycardia Ventricular Fibrillation Tachycardia, Ventricular Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013