Longitudinal Surveillance Study of the 4-SITE Lead/Header System (LSS of 4-SITE)
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|ClinicalTrials.gov Identifier: NCT01596595|
Recruitment Status : Active, not recruiting
First Posted : May 11, 2012
Last Update Posted : September 10, 2019
|Condition or disease|
|Primary Prevention of Sudden Cardiac Arrest Secondary Prevention of Sudden Cardiac Arrest|
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|
|Actual Enrollment :||1820 participants|
|Official Title:||Longitudinal Surveillance Study of the 4-SITE Lead/Header System|
|Actual Study Start Date :||April 2013|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Medically Indicated for ICD or CRT-D
Medically Indicated for ICD or CRT-D implantation per guidelines
- 5 Year Chronic Lead Complication Free Rate [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596595
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|Principal Investigator:||Stephen Kutalek, MD||Drexel University, USA|