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Longitudinal Surveillance Study of the 4-SITE Lead/Header System (LSS of 4-SITE)

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ClinicalTrials.gov Identifier: NCT01596595
Recruitment Status : Active, not recruiting
First Posted : May 11, 2012
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
Post-approval studies of implanted leads provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting. The goal of the study is to evaluate, document and report on the appropriate clinical performance, long-term reliability and the functional integrity of the Boston Scientific ENDOTAK RELIANCE® 4-SITE™ Lead and the pulse generator 4-SITE Header.

Condition or disease
Primary Prevention of Sudden Cardiac Arrest Secondary Prevention of Sudden Cardiac Arrest

Detailed Description:

The objective of the LSS of 4-SITE Study is to prospectively determine the chronic complication-free rate of the 4-SITE Lead/Header System in order to verify its clinical performance, long-term reliability and functional integrity. The LSS of 4-SITE Study is a non-randomized, multi-center, global clinical investigation of subjects implanted with the 4-SITE Lead/Header System. The study is designed to collect product performance information, any reportable adverse events and withdrawal data.

The primary purpose of this study is to evaluate, document and report on the appropriate clinical performance, the long-term reliability and the functional integrity of the 4-SITE Lead/Header System. This 4-SITE Lead/Header System consists of a 4-SITE ENDOTAK® RELIANCE defibrillation lead connected to a 4-SITE Header (which is the only PG component under study) of a single or dual chamber (VR and DR) implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy ICD (CRT-D) BSC pulse generator. Additionally, system-related diagnostic information and implant data will be collected during the conduct of this study.


Study Type : Observational
Actual Enrollment : 1820 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Actual Study Start Date : April 2013
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Group/Cohort
Medically Indicated for ICD or CRT-D
Medically Indicated for ICD or CRT-D implantation per guidelines



Primary Outcome Measures :
  1. 5 Year Chronic Lead Complication Free Rate [ Time Frame: 5 years ]
    The 4-SITE Lead/Header System will be evaluated based on the "chronic 4-SITE Lead/Header System-related complication-free rate" for the five (5) year follow-up period after the index implantation. The primary endpoint analysis will include confirmed chronic 4-SITE Lead/Header System-related complications that result in study subject permanent loss of therapy, invasive intervention, injury or death.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
From Physicians patient population
Criteria

Inclusion Criteria:

  • medically indicated for ICD/CRT-D
  • received/plan to receive study lead
  • willing for long-term follow-up

Exclusion Criteria:

  • unwilling to comply with protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596595


  Show 108 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Stephen Kutalek, MD Drexel University, USA

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01596595     History of Changes
Other Study ID Numbers: LSS of 4-SITE
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: February 2017

Keywords provided by Boston Scientific Corporation:
ICD
CRT-D
Defibrillation lead

Additional relevant MeSH terms:
Heart Arrest
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Death, Sudden
Death
Pathologic Processes