Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest
Conditions
Keywords
ICD, CRT-D, Defibrillation lead
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.
Interventions
None listed
Sponsors
Boston Scientific Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years | 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. |
Countries
Australia, Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RELIANCE 4-SITE 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. | 1,790 |
| Total | 1,790 |
Baseline characteristics
| Characteristic | RELIANCE 4-SITE |
|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 19 Participant selections |
| Race/Ethnicity, Customized Asian | 24 Participant selections |
| Race/Ethnicity, Customized Black | 249 Participant selections |
| Race/Ethnicity, Customized Caucasian | 1345 Participant selections |
| Race/Ethnicity, Customized Hawaiian | 2 Participant selections |
| Race/Ethnicity, Customized Hispanic | 106 Participant selections |
| Race/Ethnicity, Customized Missing data | 8 Participant selections |
| Race/Ethnicity, Customized Not Disclosed | 39 Participant selections |
| Race/Ethnicity, Customized Other | 7 Participant selections |
| Region of Enrollment Australia | 2 participants |
| Region of Enrollment Canada | 107 participants |
| Region of Enrollment United States | 1681 participants |
| Sex: Female, Male Female | 481 Participants |
| Sex: Female, Male Male | 1309 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 327 / 1,820 |
| other Total, other adverse events | 980 / 1,820 |
| serious Total, serious adverse events | 1,017 / 1,820 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RELIANCE 4-SITE | Percentage of Participants Not Experiencing a System or Procedure Related Complication Through 5-years | 98.9 Percentage of participants |