Leader - Evaluation of Endotak Reliance

Ventricular Tachycardia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180349
• Other study ID #: Leader v. 1.0 10/04
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: April 12, 2017
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: April 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 904
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• Endotak Reliance
Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.

Locations

Country	Name	City	State
France	CH Amiens	Amiens
France	CHU Angers	Angers
France	Hôpital Angoulème	Angoulème
France	Clinique Cardiologique Aressy	Aressy
France	CH Avignon	Avignon
France	CHU du Morvan	Brest
France	Hôpital Côte de Nacre	Caen
France	CHU Henri Mondor	Créteil
France	CHU Michalon	Grenoble
France	CH Hôpital Nord	Marseille
France	CHU La Timone	Marseille
France	CHU Montpellier	Montpellier
France	CHU Brabois	Nancy
France	CHU Nantes	Nantes
France	Nouvelle Clinique Nantaise	Nantes
France	CHU Nice	Nice
France	CHU D'Orleans	Orleans
France	Clinique Bizet	Paris
France	CHG Pau	Pau
France	CHU Pontchaillou	Rennes
France	CHU Rouen	Rouen
France	Centre cardiologique du Nord	St. Denis
France	CMC Arnaud Tzanck	St. Laurent du Var
France	CHU Rangueil	Toulouse
France	Clinique St. Gatien	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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