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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01596595




Registration number
NCT01596595
Ethics application status
Date submitted
3/05/2012
Date registered
11/05/2012
Date last updated
19/03/2021

Titles & IDs
Public title
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Scientific title
Longitudinal Surveillance Study of the 4-SITE Lead/Header System
Secondary ID [1] 0 0
LSS of 4-SITE
Universal Trial Number (UTN)
Trial acronym
LSS of 4-SITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Prevention of Sudden Cardiac Arrest 0 0
Secondary Prevention of Sudden Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Medically Indicated for ICD or CRT-D - Medically Indicated for ICD or CRT-D implantation per guidelines
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years
Timepoint [1] 0 0
5 years

Eligibility
Key inclusion criteria
- medically indicated for ICD/CRT-D

- received/plan to receive study lead

- willing for long-term follow-up
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unwilling to comply with protocol

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2020
Sample size
Target
Accrual to date
Final
1820
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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United States of America
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Kansas
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United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
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State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Missouri
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State/province [20] 0 0
Montana
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State/province [21] 0 0
Nebraska
Country [22] 0 0
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New Jersey
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New York
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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State/province [28] 0 0
South Carolina
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South Dakota
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United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Virginia
Country [34] 0 0
United States of America
State/province [34] 0 0
Washington
Country [35] 0 0
United States of America
State/province [35] 0 0
West Virginia
Country [36] 0 0
United States of America
State/province [36] 0 0
Wisconsin
Country [37] 0 0
United States of America
State/province [37] 0 0
Wyoming
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01596595
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Kutalek, MD
Address 0 0
Drexel University, USA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01596595