Primary Prevention of Sudden Cardiac ArrestLSS of 4-SITENCT01596595
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
An observational study of Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 111 sites in 3 countries.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
- How many people
- 1,820 participants
- Where
- 111 sitesin 3 countries
- Study dates
- 4 Apr 2013to 18 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From Physicians patient population
Who may be able to join
- medically indicated for ICD/CRT-D
- received/plan to receive study lead
- willing for long-term follow-up
Who cannot join
- unwilling to comply with protocol
Trial locations and contacts
111 sites in 3 countries.
111 sites in 3 countries
United States104 sites
Phoebe Putney Memorial Hospital
Albany, Georgia, 31701
Providence Alaska Medical Center
Anchorage, Alaska, 99508
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
University of Colorado Hospital
Aurora, Colorado, 80045
University of Maryland Medical System
Baltimore, Maryland, 21201
MedStar Health Research Institute
Baltimore, Maryland, 21237
SouthEast Texas Clinical Research Center
Beaumont, Texas, 77702
Billings Clinic
Billings, Montana, 59107
Bloomington Hospital
Bloomington, Indiana, 47403
Bradenton Cardiology
Bradenton, Florida, 34205
Deborah Heart and Lung Center
Browns Mills, New Jersey, 08015
Providence St. Joseph Medical Center
Burbank, California, 91505
Charleston Area Medical Center
Charleston, West Virginia, 25304
Cheyenne Regional Medical Center
Cheyenne, Wyoming, 82001
University of Chicago Hospital
Chicago, Illinois, 60637
Universtity of Cincinnati
Cincinnati, Ohio, 45267
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204
Danbury Hospital
Danbury, Connecticut, 06810
South Denver Cardiology Associates, PC
Denver, Colorado, 80120
Mercy Hospital Medical Center
Des Moines, Iowa, 50314
The Iowa Clinic, PC
Des Moines, Iowa, 50314
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
Palomar Medical Center
Escondido, California, 92025
PeeDee Cardiology Associates PA
Florence, South Carolina, 29506
Broward General Medical Center
Fort Lauderdale, Florida, 33316
Parkview Memorial Hospital
Fort Wayne, Indiana, 46805
California Heart Associates
Fountain Valley, California, 92708
Luc Sinh Nguyen, MD, FACC, Inc.
Fountain Valley, California, 92708
North Florida Regional Medical Center
Gainesville, Florida, 32605
Northeast Georgia Heart Center
Gainesville, Georgia, 30501
Cardiovascular Consultants, LTD
Glendale, Arizona, 85032
Bellin Health
Green Bay, Wisconsin, 54305
Piedmont Medical Center
Greenwood, South Carolina, 29646
Illinois Heart and Vascular at Adventist Hinsdale Hospital
Hinsdale, Illinois, 60521
Houston Arrhythmia Associates
Houston, Texas, 77024
University of Mississippi Medical Center
Jackson, Mississippi, 39216
First Coast Cardiovascular
Jacksonville, Florida, 32216
Baptist Medical Center
Jacksonville, Florida, 32250
Heartland Cardiovascular Center
Joliet, Illinois, 60435
Kansas City Heart Foundation
Kansas City, Kansas, 64114
Kettering Medical Center
Kettering, Ohio, 45429
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, 30046
Lexington Medical Center
Lexington, South Carolina, 29072
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Heart Clinic Arkansas
Little Rock, Arkansas, 72205
Providence Holy Cross Medical Center
Los Angeles, California, 90024
Cardiac Device Rhythm Specialists
Los Angeles, California, 90033
Comprehensive Cardiovascular Medical Group
Los Angeles, California, 93309
Georgia Arrhythmia Consultants
Macon, Georgia, 31201
Meriter Hospital, Inc.
Madison, Wisconsin, 53713
North Shore University Hospital
Manhasset, New York, 11030
Cardiovascular Associates of Mesa
Mesa, Arizona, 85206
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
St. Patrick Hospital
Missoula, Montana, 59802
Monongalia General Hospital
Morgantown, West Virginia, 26505
Intermountain Medical Center
Murray, Utah, 84107
Saint Thomas Health
Nashville, Tennessee, 37205
Yale University School of Medicine
New Haven, Connecticut, 06520
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
The Arrhythmia Institute
Newton, Pennsylvania, 18940
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Desert Regional Medical Center
Palm Springs, California, 62262
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102
Phoenix Cardiovascular Research Group
Phoenix, Arizona, 85006
Charlotte Heart & Vascular
Port Charlotte, Florida, 33952
Southcoast Physicians Group
Providence, Rhode Island, 02904
Rapid City Regional Hospit
Rapid City, South Dakota, 57701
Virginia Commonwealth University Health System
Richmond, Virginia, 23219
Truong D. Duong, MD. A Medical Corporation
Riverside, California, 92503
Rochester General Hospital
Rochester, New York, 14621
Brevard Cardiovascular Research Associates, Inc.
Rockledge, Florida, 32955
Wellmont Holston Valley Medical Center
Rogersville, Tennessee, 37857
Covenant Medical Center
Saginaw, Michigan, 48602
Centracare Heart and Vascular Center
Saint Cloud, Minnesota, 56303
Salem Hospital
Salem, Oregon, 97302
University of Utah Hospital and Clinics
Salt Lake City, Utah, 84132
Arrhythmia Associates of South Texas
San Antonio, Texas, 78217
San Diego Arrhythmia Associates
San Diego, California, 92103
Good Samaritan Hospital - San Jose
San Jose, California, 95124
Santa Barbara Cottage Hospital
Santa Barbara, California, 93102
Virginia Mason Medical Center
Seattle, Washington, 98101
Cardiovascular Associates of the Delaware Valley
Sewell, New Jersey, 08080
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Cox Health
Springfield, Missouri, 65807
St. Louis University Hospital
St Louis, Missouri, 63104
Washington University School of Medicine
St Louis, Missouri, 63110
Atlanta Heart Associates
Stockbridge, Georgia, 30281
SUNY-Stony Brook School of Medicine
Stony Brook, New York, 24421
Tallahassee Memorial Hospital
Tallahassee, Florida, 32308
Tampa General Hospital
Tampa, Florida, 33606
The Toledo Hospital
Toledo, Ohio, 43615
Little Company of Mary Hospital
Torrance, California, 90503
Munson Medical Center
Traverse City, Michigan, 49684
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Trinity Mother Frances Health System
Tyler, Texas, 75701
Carle Foundation Hospital
Urbana, Illinois, 61801
Via-Christi Regional Medical Center
Wichita, Kansas, 67214
Cardiology Group of West New York
Williamsville, New York, 14221
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
Genesis Healthcare System
Zanesville, Ohio, 43701
Canada6 sites
Foothills Medical Centre
Calgary, Alberta
University of Alberta Hospital
Edmonton, Alberta
Hamilton General Hospital
Hamilton, Ontario, L8L 2X2
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7
Fleurimont Hospital
Sherbrooke, Quebec, J1H5N4
Institut universitaire de Cardiologie et de Pneumologie de Quebec
Ste Foy, Quebec, G1V 4G5
About this study
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.
Read the 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.
- Conditions
- Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
- Keywords
- ICD, CRT-D, Defibrillation lead
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Medically Indicated for ICD or CRT-D | Medically Indicated for ICD or CRT-D implantation per guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study start4 Apr 2013
- Primary completion18 Feb 2020
- Study completion18 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Prevention of Sudden Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,820 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Kutalek, MD, Principal investigator, Drexel University, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596595
- Sponsor's protocol ID
- LSS of 4-SITE
- Acronym
- LSS of 4-SITE
- Status last verified
- Feb 2021
- First submitted
- 3 May 2012
- Last updated
- 19 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Surveillance Study of the 4-SITE Lead/Header System
- ClinicalTrials.gov ID
- NCT01596595
- Acronym / sponsor ID
- LSS of 4-SITE / LSS of 4-SITE
- Conditions
- Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
- Keywords
- ICD, CRT-D, Defibrillation lead
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,820 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2013 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 18 Feb 2020 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 21 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medically Indicated for ICD or CRT-D | – | –Medically Indicated for ICD or CRT-D implantation per guidelines |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From Physicians patient population
Key inclusion criteria (3 listed)
- medically indicated for ICD/CRT-D
- received/plan to receive study lead
- willing for long-term follow-up
Key exclusion criteria (1 listed)
- unwilling to comply with protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Kutalek, MD principal investigator
Drexel University, USA
111 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest, run by Boston Scientific Corporation at 111 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 111 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021; AzTrials last refreshed its copy on 6 Nov 2026.