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

This study is not yet open for participant recruitment.
Verified November 2012 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01596595
First received: May 3, 2012
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

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
Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Longitudinal Surveillance Study of the 4-SITE Lead/Header System

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest
U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 5 Year Chronic Lead Complication Free Rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 1780
Study Start Date: March 2013
Estimated Study Completion Date: August 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
Medically Indicated for ICD or CRT-D
Medically Indicated for ICD or CRT-D implantation per guidelines

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596595

Contacts
Contact: Anne Swearingen, MSN 800-227-3422 ext 24270 anne.swearingen@bsci.com

Locations
United States, Pennsylvania
Not yet recruiting
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Stephen Kutalek, MD Drexel University, USA
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01596595     History of Changes
Other Study ID Numbers: LSS of 4-SITE
Study First Received: May 3, 2012
Last Updated: November 16, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013