Leader - Evaluation of Endotak Reliance

Completed

• Conditions: Ventricular Fibrillation; Ventricular Tachycardia

• Registration Number: NCT00180349
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-12
• Last Update Posted: 2017-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 904

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Defibrillation testing (DT) procedures and consequences on clinical outcomes	during 1 year follow-up	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

Trial Locations

Locations (25)

Clinique Cardiologique Aressy; 🇫🇷 Aressy, France

Hôpital Côte de Nacre; 🇫🇷 Caen, France

CHU Montpellier; 🇫🇷 Montpellier, France

CHU Brabois; 🇫🇷 Nancy, France

CHU Angers; 🇫🇷 Angers, France

CHU Rangueil; 🇫🇷 Toulouse, France

CH Avignon; 🇫🇷 Avignon, France

CMC Arnaud Tzanck; 🇫🇷 St. Laurent du Var, France

CH Amiens; 🇫🇷 Amiens, France

Hôpital Angoulème; 🇫🇷 Angoulème, France

CHU Henri Mondor; 🇫🇷 Créteil, France

CHU La Timone; 🇫🇷 Marseille, France

Nouvelle Clinique Nantaise; 🇫🇷 Nantes, France

CHU du Morvan; 🇫🇷 Brest, France

CHG Pau; 🇫🇷 Pau, France

CHU Pontchaillou; 🇫🇷 Rennes, France

CHU Rouen; 🇫🇷 Rouen, France

CH Hôpital Nord; 🇫🇷 Marseille, France

CHU Michalon; 🇫🇷 Grenoble, France

CHU D'Orleans; 🇫🇷 Orleans, France

Clinique Bizet; 🇫🇷 Paris, France

Clinique St. Gatien; 🇫🇷 Tours, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nice; 🇫🇷 Nice, France

Centre cardiologique du Nord; 🇫🇷 St. Denis, France