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

February 25, 2021 updated by: Boston Scientific Corporation
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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

1820

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Mount Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Foothills Medical Centre
      • Edmonton, Alberta, Canada
        • University of Alberta Hospital
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Fleurimont Hospital
      • Ste Foy, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Providence Alaska Medical Center
    • Arizona
      • Glendale, Arizona, United States, 85032
        • Cardiovascular Consultants, Ltd
      • Mesa, Arizona, United States, 85206
        • CardioVascular Associates of Mesa
      • Phoenix, Arizona, United States, 85006
        • Phoenix Cardiovascular Research Group
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Heart Clinic Arkansas
    • California
      • Burbank, California, United States, 91505
        • Providence St. Joseph Medical Center
      • Escondido, California, United States, 92025
        • Palomar Medical Center
      • Fountain Valley, California, United States, 92708
        • California Heart Associates
      • Fountain Valley, California, United States, 92708
        • Luc Sinh Nguyen, MD, FACC, Inc.
      • Los Angeles, California, United States, 90033
        • Cardiac Device Rhythm Specialists
      • Los Angeles, California, United States, 90024
        • Providence Holy Cross Medical Center
      • Los Angeles, California, United States, 93309
        • Comprehensive Cardiovascular Medical Group
      • Palm Springs, California, United States, 62262
        • Desert Regional Medical Center
      • Riverside, California, United States, 92503
        • Truong D. Duong, MD. A Medical Corporation
      • San Diego, California, United States, 92103
        • San Diego Arrhythmia Associates
      • San Jose, California, United States, 95124
        • Good Samaritan Hospital - San Jose
      • Santa Barbara, California, United States, 93102
        • Santa Barbara Cottage Hospital
      • Torrance, California, United States, 90503
        • Little Company of Mary Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Denver, Colorado, United States, 80120
        • South Denver Cardiology Associates, PC
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bradenton Cardiology
      • Clearwater, Florida, United States, 33756
        • Clearwater Cardiovascular Consultants
      • Fort Lauderdale, Florida, United States, 33316
        • Broward General Medical Center
      • Gainesville, Florida, United States, 32605
        • North Florida Regional Medical Center
      • Jacksonville, Florida, United States, 32216
        • First Coast Cardiovascular
      • Jacksonville, Florida, United States, 32250
        • Baptist Medical Center
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Medical Center
      • Miami, Florida, United States, 33173
        • Cardiovascular Research Center of South Florida
      • Port Charlotte, Florida, United States, 33952
        • Charlotte Heart & Vascular
      • Rockledge, Florida, United States, 32955
        • Brevard Cardiovascular Research Associates, Inc.
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Memorial Hospital
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
    • Georgia
      • Albany, Georgia, United States, 31701
        • Phoebe Putney Memorial Hospital
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
      • Lawrenceville, Georgia, United States, 30046
        • Gwinnett Hospital System Inc.
      • Macon, Georgia, United States, 31201
        • Georgia Arrhythmia Consultants
      • Stockbridge, Georgia, United States, 30281
        • Atlanta Heart Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospital
      • Hinsdale, Illinois, United States, 60521
        • Illinois Heart and Vascular at Adventist Hinsdale Hospital
      • Joliet, Illinois, United States, 60435
        • Heartland Cardiovascular Center
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital
    • Indiana
      • Bloomington, Indiana, United States, 47403
        • Bloomington Hospital
      • Fort Wayne, Indiana, United States, 46805
        • Parkview Memorial Hospital
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Mercy Hospital Medical Center
      • Des Moines, Iowa, United States, 50314
        • The Iowa Clinic, PC
    • Kansas
      • Kansas City, Kansas, United States, 64114
        • Kansas City Heart Foundation
      • Wichita, Kansas, United States, 67214
        • Via-Christi Regional Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical System
      • Baltimore, Maryland, United States, 21237
        • Medstar Health Research Institute
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Saginaw, Michigan, United States, 48602
        • Covenant Medical Center
      • Traverse City, Michigan, United States, 49684
        • Munson Medical Center
    • Minnesota
      • Saint Cloud, Minnesota, United States, 56303
        • CentraCare Heart and Vascular Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63104
        • St. Louis University Hospital
      • Springfield, Missouri, United States, 65807
        • Cox Health
    • Montana
      • Billings, Montana, United States, 59107
        • Billings Clinic
      • Missoula, Montana, United States, 59802
        • St. Patrick Hospital
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Nebraska Heart Institute
    • New Jersey
      • Browns Mills, New Jersey, United States, 08015
        • Deborah Heart and Lung Center
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center
      • Sewell, New Jersey, United States, 08080
        • Cardiovascular Associates of the Delaware Valley
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Stony Brook, New York, United States, 24421
        • SUNY-Stony Brook School of Medicine
      • Williamsville, New York, United States, 14221
        • Cardiology Group of West New York
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Universtity of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center
      • Toledo, Ohio, United States, 43615
        • The Toledo Hospital
      • Zanesville, Ohio, United States, 43701
        • Genesis HealthCare System
    • Oregon
      • Salem, Oregon, United States, 97302
        • Salem Hospital
    • Pennsylvania
      • Newton, Pennsylvania, United States, 18940
        • The Arrhythmia Institute
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel University College of Medicine
      • Yardley, Pennsylvania, United States, 19067
        • Cardiology Consultants of Philadelphia
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Southcoast Physicians Group
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Sisters of Charity Providence Hospital
      • Florence, South Carolina, United States, 29506
        • PeeDee Cardiology Associates PA
      • Greenwood, South Carolina, United States, 29646
        • Piedmont Medical Center
      • Lexington, South Carolina, United States, 29072
        • Lexington Medical Center
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospit
    • Tennessee
      • Nashville, Tennessee, United States, 37205
        • Saint Thomas Health
      • Rogersville, Tennessee, United States, 37857
        • Wellmont Holston Valley Medical Center
    • Texas
      • Beaumont, Texas, United States, 77702
        • Southeast Texas Clinical Research Center
      • Houston, Texas, United States, 77024
        • Houston Arrhythmia Associates
      • San Antonio, Texas, United States, 78217
        • Arrhythmia Associates of South Texas
      • Tyler, Texas, United States, 75701
        • Trinity Mother Frances Health System
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Hospital and Clinics
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
      • Richmond, Virginia, United States, 23219
        • Virginia Commonwealth University Health System
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Charleston Area Medical Center
      • Morgantown, West Virginia, United States, 26505
        • Monongalia General Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54305
        • Bellin Health
      • Madison, Wisconsin, United States, 53713
        • Meriter Hospital, Inc.
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

From Physicians patient population

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Stephen Kutalek, MD, Drexel University, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 4, 2013

Primary Completion (ACTUAL)

February 18, 2020

Study Completion (ACTUAL)

February 18, 2020

Study Registration Dates

First Submitted

May 3, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (ESTIMATE)

May 11, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 19, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSS of 4-SITE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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