Leader - Evaluation of Endotak Reliance

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

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Intervention / Treatment: Device: Endotak Reliance

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 Type: Observational
• Enrollment (Actual): 904

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CH Amiens
  • Angers, France, 49033
    • CHU Angers
  • Angoulème, France, 16470
    • Hopital Angouleme
  • Aressy, France, 64320
    • Clinique Cardiologique Aressy
  • Avignon, France, 84902
    • Ch Avignon
  • Brest, France, 29609
    • CHU du Morvan
  • Caen, France, 14033
    • Hopital Cote de Nacre
  • Créteil, France, 94000
    • CHU Henri Mondor
  • Grenoble, France, 38043
    • CHU Michalon
  • Marseille, France, 13385
    • CHU La Timone
  • Marseille, France, 13008
    • CH Hôpital Nord
  • Montpellier, France, 34295
    • Chu Montpellier
  • Nancy, France
    • CHU Brabois
  • Nantes, France, 44000
    • Nouvelle Clinique Nantaise
  • Nantes, France, 44295
    • CHU Nantes
  • Nice, France, 06002
    • CHU Nice
  • Orleans, France, 45000
    • CHU d'ORLEANS
  • Paris, France
    • Clinique Bizet
  • Pau, France, 64046
    • CHG Pau
  • Rennes, France, 35033
    • CHU Pontchaillou
  • Rouen, France, 76031
    • CHU Rouen
  • St. Denis, France, 93000
    • Centre Cardiologique du Nord
  • St. Laurent du Var, France, 6700
    • CMC Arnaud Tzanck
  • Toulouse, France, 31403
    • CHU Rangueil
  • Tours, France, 37000
    • Clinique St. Gatien

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with the indication for an implantable ICD are invited to participate.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Nicolas Sadoul, MD, CHU Brabois, Nancy; Principal Investigator: Arnaud Lazarus, MD, Clinique Bizet, Paris

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Actual): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Ventricular Fibrillation; Tachycardia; Tachycardia, Ventricular
• Other Study ID Numbers: Leader v. 1.0 10/04