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

Primary Prevention of Sudden Cardiac Arrest Clinical Trial

— LSS of 4-SITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596595
• Other study ID #: LSS of 4-SITE
• Status: Completed
• Start date: April 4, 2013
• Est. completion date: February 18, 2020

Study information

• Verified date: February 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1820
• Est. completion date: February 18, 2020
• Est. primary completion date: February 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death, Sudden, Cardiac
• Heart Arrest
• Primary Prevention of Sudden Cardiac Arrest
• Secondary Prevention of Sudden Cardiac Arrest

Locations

Country	Name	City	State
Australia	Mount Hospital	Perth	Western Australia
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Royal Columbian Hospital	New Westminster	British Columbia
Canada	Fleurimont Hospital	Sherbrooke	Quebec
Canada	Institut universitaire de Cardiologie et de Pneumologie de Quebec	Ste Foy	Quebec
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Colorado Hospital	Aurora	Colorado
United States	MedStar Health Research Institute	Baltimore	Maryland
United States	University of Maryland Medical System	Baltimore	Maryland
United States	SouthEast Texas Clinical Research Center	Beaumont	Texas
United States	Billings Clinic	Billings	Montana
United States	Bloomington Hospital	Bloomington	Indiana
United States	Bradenton Cardiology	Bradenton	Florida
United States	Deborah Heart and Lung Center	Browns Mills	New Jersey
United States	Providence St. Joseph Medical Center	Burbank	California
United States	Charleston Area Medical Center	Charleston	West Virginia
United States	Cheyenne Regional Medical Center	Cheyenne	Wyoming
United States	University of Chicago Hospital	Chicago	Illinois
United States	Universtity of Cincinnati	Cincinnati	Ohio
United States	Clearwater Cardiovascular Consultants	Clearwater	Florida
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Sisters of Charity Providence Hospital	Columbia	South Carolina
United States	Danbury Hospital	Danbury	Connecticut
United States	South Denver Cardiology Associates, PC	Denver	Colorado
United States	Mercy Hospital Medical Center	Des Moines	Iowa
United States	The Iowa Clinic, PC	Des Moines	Iowa
United States	Englewood Hospital and Medical Center	Englewood	New Jersey
United States	Palomar Medical Center	Escondido	California
United States	PeeDee Cardiology Associates PA	Florence	South Carolina
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Parkview Memorial Hospital	Fort Wayne	Indiana
United States	California Heart Associates	Fountain Valley	California
United States	Luc Sinh Nguyen, MD, FACC, Inc.	Fountain Valley	California
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Northeast Georgia Heart Center	Gainesville	Georgia
United States	Cardiovascular Consultants, LTD	Glendale	Arizona
United States	Bellin Health	Green Bay	Wisconsin
United States	Piedmont Medical Center	Greenwood	South Carolina
United States	Illinois Heart and Vascular at Adventist Hinsdale Hospital	Hinsdale	Illinois
United States	Houston Arrhythmia Associates	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Baptist Medical Center	Jacksonville	Florida
United States	First Coast Cardiovascular	Jacksonville	Florida
United States	Heartland Cardiovascular Center	Joliet	Illinois
United States	Kansas City Heart Foundation	Kansas City	Kansas
United States	Kettering Medical Center	Kettering	Ohio
United States	Osceola Regional Medical Center	Kissimmee	Florida
United States	Gwinnett Hospital System Inc.	Lawrenceville	Georgia
United States	Lexington Medical Center	Lexington	South Carolina
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Heart Clinic Arkansas	Little Rock	Arkansas
United States	Cardiac Device Rhythm Specialists	Los Angeles	California
United States	Comprehensive Cardiovascular Medical Group	Los Angeles	California
United States	Providence Holy Cross Medical Center	Los Angeles	California
United States	Georgia Arrhythmia Consultants	Macon	Georgia
United States	Meriter Hospital, Inc.	Madison	Wisconsin
United States	North Shore University Hospital	Manhasset	New York
United States	Cardiovascular Associates of Mesa	Mesa	Arizona
United States	Cardiovascular Research Center of South Florida	Miami	Florida
United States	St. Patrick Hospital	Missoula	Montana
United States	Monongalia General Hospital	Morgantown	West Virginia
United States	Intermountain Medical Center	Murray	Utah
United States	Saint Thomas Health	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	The Arrhythmia Institute	Newton	Pennsylvania
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Desert Regional Medical Center	Palm Springs	California
United States	Drexel University College of Medicine	Philadelphia	Pennsylvania
United States	Phoenix Cardiovascular Research Group	Phoenix	Arizona
United States	Charlotte Heart & Vascular	Port Charlotte	Florida
United States	Southcoast Physicians Group	Providence	Rhode Island
United States	Rapid City Regional Hospit	Rapid City	South Dakota
United States	Virginia Commonwealth University Health System	Richmond	Virginia
United States	Truong D. Duong, MD. A Medical Corporation	Riverside	California
United States	Rochester General Hospital	Rochester	New York
United States	Brevard Cardiovascular Research Associates, Inc.	Rockledge	Florida
United States	Wellmont Holston Valley Medical Center	Rogersville	Tennessee
United States	Covenant Medical Center	Saginaw	Michigan
United States	Centracare Heart and Vascular Center	Saint Cloud	Minnesota
United States	St. Louis University Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Salem Hospital	Salem	Oregon
United States	University of Utah Hospital and Clinics	Salt Lake City	Utah
United States	Arrhythmia Associates of South Texas	San Antonio	Texas
United States	San Diego Arrhythmia Associates	San Diego	California
United States	Good Samaritan Hospital - San Jose	San Jose	California
United States	Santa Barbara Cottage Hospital	Santa Barbara	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Cardiovascular Associates of the Delaware Valley	Sewell	New Jersey
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Cox Health	Springfield	Missouri
United States	Atlanta Heart Associates	Stockbridge	Georgia
United States	SUNY-Stony Brook School of Medicine	Stony Brook	New York
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Tampa General Hospital	Tampa	Florida
United States	The Toledo Hospital	Toledo	Ohio
United States	Little Company of Mary Hospital	Torrance	California
United States	Munson Medical Center	Traverse City	Michigan
United States	North Mississippi Medical Center	Tupelo	Mississippi
United States	Trinity Mother Frances Health System	Tyler	Texas
United States	Carle Foundation Hospital	Urbana	Illinois
United States	Via-Christi Regional Medical Center	Wichita	Kansas
United States	Cardiology Group of West New York	Williamsville	New York
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania
United States	Genesis Healthcare System	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 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