An observational study in Primary Prevention of Sudden Cardiac Arrest and Secondary Prevention of Sudden Cardiac Arrest, sponsored by Boston Scientific Corporation. Completed at 111 sites in 3 countries. Per ClinicalTrials.gov, last updated 2021-03-19.
Sponsored by Boston Scientific Corporation · Observational
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.
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.
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 1,820 is above the median of 200 across 383 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →Boston Scientific Corporation is the lead sponsor of 517 studies on the registry; 38 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 56 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
From Physicians patient population
Exclusion Criteria:
Medically Indicated for ICD or CRT-D implantation per guidelines
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.
Time frame: 5 years
| Milestone | RELIANCE 4-SITE |
|---|---|
| Started | 1779 |
| Completed | 814 |
| Not completed | 965 |
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.
| Percentage of participants | RELIANCE 4-SITE |
|---|---|
| Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years | 98.9 (98.5 to NA) |
Collected over Adverse event data were collected from the time of enrollment until subjects ended their participation in the study. Subjects were considered to have completed the study after 60-Months of follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| RELIANCE 4-SITE | 327/1,820 (18%) | 1,017/1,820 (55.9%) | 980/1,820 (53.8%) |
| Event | RELIANCE 4-SITE |
|---|---|
| GastrointestinalGastrointestinal disorders | 188/1820 |
| Multiple Heart Failure SymptomsCardiac disorders | 185/1820 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 183/1820 |
| Heart Failure Symptoms - UnspecifiedCardiac disorders | 142/1820 |
| Dyspnea - Heart FailureCardiac disorders | 108/1820 |
| RenalRenal and urinary disorders | 108/1820 |
| Atrial Fibrillation (AF)Cardiac disorders | 83/1820 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 83/1820 |
| System InfectionInfections and infestations | 76/1820 |
| Physical TraumaGeneral disorders | 76/1820 |
| Event | RELIANCE 4-SITE |
|---|---|
| Head, eyes, ears, nose, throat (HEENT)General disorders | 185/1820 |
| GastrointestinalGastrointestinal disorders | 166/1820 |
| MusculoskeletalMusculoskeletal and connective tissue disorders | 165/1820 |
| PulmonaryRespiratory, thoracic and mediastinal disorders | 123/1820 |
| Atrial Fibrillation (AF)Cardiac disorders | 111/1820 |
| Patient Condition - Non-Cardiovascular - OTHERGeneral disorders | 109/1820 |
| IntegumentarySkin and subcutaneous tissue disorders | 99/1820 |
| Physical TraumaGeneral disorders | 97/1820 |
| Abnormal Laboratory ValuesGeneral disorders | 95/1820 |
| GenitourinaryRenal and urinary disorders | 95/1820 |
Baseline characteristics include enrolled subjects who were implanted (1779) or attempted for implant (11) of an ENDOTAK® RELIANCE 4-SITE lead and Boston Scientific pulse generator compatible with the RELIANCE 4-SITE family of cardiac leads. Intent subjects (30) are not included in the baseline characteristics.
| Age, Continuous(years) | RELIANCE 4-SITE |
|---|---|
| Mean | 64.0 ± 12.0 |
| Sex: Female, Male(Participants) | RELIANCE 4-SITE |
|---|---|
| Female | 481 |
| Male | 1309 |
| Race/Ethnicity, Customized(Participant selections) | RELIANCE 4-SITE |
|---|---|
| Caucasian | 1345 |
| Black | 249 |
| Hispanic | 106 |
| Not Disclosed | 39 |
| Asian | 24 |
| American Indian or Alaska Native | 19 |
| Hawaiian | 2 |
| Other | 7 |
| Missing data | 8 |
| Region of Enrollment(participants) | RELIANCE 4-SITE |
|---|---|
| Canada | 107 |
| United States | 1681 |
| Australia | 2 |
Showing the first 100 of 111 sites across 3 countries.
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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