Clinical trial NCT00180349: Leader - Evaluation of Endotak Reliance
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-16
Enrollment: 904
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with the indication for an implantable ICD are invited to participate.

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.

Eligibility 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

Primary outcomes:
measure: Defibrillation testing (DT) procedures and consequences on clinical outcomes
timeFrame: at implant
measure: Defibrillation testing (DT) procedures and consequences on clinical outcomes
timeFrame: during 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CH Amiens
city: Angers
country: France
facility: CHU Angers
city: Angoulème
country: France
facility: Hôpital Angoulème
city: Aressy
country: France
facility: Clinique Cardiologique Aressy
city: Avignon
country: France
facility: CH Avignon
city: Brest
country: France
facility: CHU du Morvan
city: Caen
country: France
facility: Hôpital Côte de Nacre
city: Créteil
country: France
facility: CHU Henri Mondor
city: Grenoble
country: France
facility: CHU Michalon
city: Marseille
country: France
facility: CH Hôpital Nord
city: Marseille
country: France
facility: CHU La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHU Brabois
city: Nantes
country: France
facility: Nouvelle Clinique Nantaise
city: Nantes
country: France
facility: CHU Nantes
city: Nice
country: France
facility: CHU Nice
city: Orleans
country: France
facility: CHU D'Orleans
city: Paris
country: France
facility: Clinique Bizet
city: Pau
country: France
facility: CHG Pau
city: Rennes
country: France
facility: CHU Pontchaillou
city: Rouen
country: France
facility: CHU Rouen
city: St. Denis
country: France
facility: Centre cardiologique du Nord
city: St. Laurent du Var
country: France
facility: CMC Arnaud Tzanck
city: Toulouse
country: France
facility: CHU Rangueil
city: Tours
country: France
facility: Clinique St. Gatien
Study officials:
affiliation: CHU Brabois, Nancy
name: Nicolas Sadoul, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Bizet, Paris
name: Arnaud Lazarus, MD
role: PRINCIPAL_INVESTIGATOR
References: