Clinical trial NCT01596595: Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Official title: Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Prevention of Sudden Cardiac Arrest
Secondary Prevention of Sudden Cardiac Arrest
Keywords: ICD
CRT-D
Defibrillation lead
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2012-05-11
Enrollment: 1820
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From Physicians patient population

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.

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 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

Primary outcomes:
measure: Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Providence Alaska Medical Center
state: Alaska
city: Glendale
country: United States
facility: Cardiovascular Consultants, LTD
state: Arizona
city: Mesa
country: United States
facility: Cardiovascular Associates of Mesa
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Cardiovascular Research Group
state: Arizona
city: Little Rock
country: United States
facility: Heart Clinic Arkansas
state: Arkansas
city: Burbank
country: United States
facility: Providence St. Joseph Medical Center
state: California
city: Escondido
country: United States
facility: Palomar Medical Center
state: California
city: Fountain Valley
country: United States
facility: California Heart Associates
state: California
city: Fountain Valley
country: United States
facility: Luc Sinh Nguyen, MD, FACC, Inc.
state: California
city: Los Angeles
country: United States
facility: Providence Holy Cross Medical Center
state: California
city: Los Angeles
country: United States
facility: Cardiac Device Rhythm Specialists
state: California
city: Los Angeles
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: Palm Springs
country: United States
facility: Desert Regional Medical Center
state: California
city: Riverside
country: United States
facility: Truong D. Duong, MD. A Medical Corporation
state: California
city: San Diego
country: United States
facility: San Diego Arrhythmia Associates
state: California
city: San Jose
country: United States
facility: Good Samaritan Hospital - San Jose
state: California
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
city: Torrance
country: United States
facility: Little Company of Mary Hospital
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Denver
country: United States
facility: South Denver Cardiology Associates, PC
state: Colorado
city: Danbury
country: United States
facility: Danbury Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bradenton
country: United States
facility: Bradenton Cardiology
state: Florida
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: Broward General Medical Center
state: Florida
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular
state: Florida
city: Jacksonville
country: United States
facility: Baptist Medical Center
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart & Vascular
state: Florida
city: Rockledge
country: United States
facility: Brevard Cardiovascular Research Associates, Inc.
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Albany
country: United States
facility: Phoebe Putney Memorial Hospital
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Lawrenceville
country: United States
facility: Gwinnett Hospital System Inc.
state: Georgia
city: Macon
country: United States
facility: Georgia Arrhythmia Consultants
state: Georgia
city: Stockbridge
country: United States
facility: Atlanta Heart Associates
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Hospital
state: Illinois
city: Hinsdale
country: United States
facility: Illinois Heart and Vascular at Adventist Hinsdale Hospital
state: Illinois
city: Joliet
country: United States
facility: Heartland Cardiovascular Center
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Bloomington
country: United States
facility: Bloomington Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Memorial Hospital
state: Indiana
city: Des Moines
country: United States
facility: Mercy Hospital Medical Center
state: Iowa
city: Des Moines
country: United States
facility: The Iowa Clinic, PC
state: Iowa
city: Kansas City
country: United States
facility: Kansas City Heart Foundation
state: Kansas
city: Wichita
country: United States
facility: Via-Christi Regional Medical Center
state: Kansas
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical System
state: Maryland
city: Baltimore
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Traverse City
country: United States
facility: Munson Medical Center
state: Michigan
city: Saint Cloud
country: United States
facility: Centracare Heart and Vascular Center
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Tupelo
country: United States
facility: North Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Springfield
country: United States
facility: Cox Health
state: Missouri
city: Billings
country: United States
facility: Billings Clinic
state: Montana
city: Missoula
country: United States
facility: St. Patrick Hospital
state: Montana
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Browns Mills
country: United States
facility: Deborah Heart and Lung Center
state: New Jersey
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center
state: New Jersey
city: Sewell
country: United States
facility: Cardiovascular Associates of the Delaware Valley
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY-Stony Brook School of Medicine
state: New York
city: Williamsville
country: United States
facility: Cardiology Group of West New York
state: New York
city: Cincinnati
country: United States
facility: Universtity of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Toledo
country: United States
facility: The Toledo Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Healthcare System
state: Ohio
city: Salem
country: United States
facility: Salem Hospital
state: Oregon
city: Newton
country: United States
facility: The Arrhythmia Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Providence
country: United States
facility: Southcoast Physicians Group
state: Rhode Island
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Florence
country: United States
facility: PeeDee Cardiology Associates PA
state: South Carolina
city: Greenwood
country: United States
facility: Piedmont Medical Center
state: South Carolina
city: Lexington
country: United States
facility: Lexington Medical Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Regional Hospit
state: South Dakota
city: Nashville
country: United States
facility: Saint Thomas Health
state: Tennessee
city: Rogersville
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Beaumont
country: United States
facility: SouthEast Texas Clinical Research Center
state: Texas
city: Houston
country: United States
facility: Houston Arrhythmia Associates
state: Texas
city: San Antonio
country: United States
facility: Arrhythmia Associates of South Texas
state: Texas
city: Tyler
country: United States
facility: Trinity Mother Frances Health System
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital and Clinics
state: Utah
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Charleston
country: United States
facility: Charleston Area Medical Center
state: West Virginia
city: Morgantown
country: United States
facility: Monongalia General Hospital
state: West Virginia
city: Green Bay
country: United States
facility: Bellin Health
state: Wisconsin
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
city: Cheyenne
country: United States
facility: Cheyenne Regional Medical Center
state: Wyoming
city: Perth
country: Australia
facility: Mount Hospital
state: Western Australia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: New Westminster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Sherbrooke
country: Canada
facility: Fleurimont Hospital
state: Quebec
city: Ste Foy
country: Canada
facility: Institut universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
Study officials:
affiliation: Drexel University, USA
name: Stephen Kutalek, MD
role: PRINCIPAL_INVESTIGATOR
References: