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Leader - Evaluation of Endotak Reliance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00180349
First received: September 12, 2005
Last updated: April 12, 2017
Last verified: April 2017
  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
Ventricular Tachycardia Ventricular Fibrillation Device: Endotak Reliance

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 Boston Scientific Corporation:

Primary Outcome Measures:
  • Defibrillation testing (DT) procedures and consequences on clinical outcomes [ Time Frame: at implant ]
    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

  • Defibrillation testing (DT) procedures and consequences on clinical outcomes [ Time Frame: 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


Enrollment: 904
Study Start Date: December 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Endotak Reliance
    Endotak Reliance is a defibrillation lead delivering pacing and defibrillation therapy to the ventricle as needed.
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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
CH Hôpital Nord
Marseille, France, 13008
CHU La Timone
Marseille, France, 13385
CHU Montpellier
Montpellier, France, 34295
CHU Brabois
Nancy, France
Nouvelle Clinique Nantaise
Nantes, France, 44000
CHU Nantes
Nantes, France, 44295
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
Boston Scientific Corporation
Investigators
Principal Investigator: Nicolas Sadoul, MD CHU Brabois, Nancy
Principal Investigator: Arnaud Lazarus, MD Clinique Bizet, Paris
  More Information

Responsible Party: Boston Scientific Corporation
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: April 12, 2017

Additional relevant MeSH terms:
Tachycardia
Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2017