Longitudinal Surveillance Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 2,500
Study Overview
Brief Summary
Boston Scientific CRM's Longitudinal Surveillance Registry (LSR) will serve as an active ongoing source of updated information on the long-term reliability and performance of BSC commercially available leads and LATITUDE-enabled (wireless or wanded) pulse generators (PGs).
Detailed Description
The LSR is an active, prospective, non-randomized, multi-center registry of patients implanted with BSC commercially available LATITUDE-enabled products. The primary purpose of the LSR is to evaluate and report on the long-term reliability and clinical performance of BSC's commercially available PGs and leads using the LATITUDE Patient Management system to augment information collected from in-clinic visits. The LSR is designed to enroll patients implanted with BSC LATITUDE-enabled (wireless or wanded) commercially available PGs (lead systems may include other manufacturers' leads).
The primary objective of the LSR is to prospectively evaluate market-released PGs and leads to verify long-term system performance. The secondary objectives of the LSR include:
I. To compare PG- and lead-related reliability data collected via LATITUDE with PG- and lead-related reliability data collected at in-clinic visits II. To compare this active surveillance of BSC PG and lead reliability data to the current passive surveillance system III. To enhance understanding of feature performance, patient management and clinical outcomes
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient who is or is scheduled to be implanted within 30 days of signing the consent with a currently available BSC PG (lead systems may include other manufacturers' leads) that can be followed on the LATITUDE Patient Management system
- •Patient who plans to remain in the long-term care of his/her enrolling physician (must be followed in-clinic at least once every 24 months by his/her enrolling physician)
- •Patient who confirms that s/he has a telephone line compatible with the LATITUDE Patient Management system Communicator
- •Patient or appropriate legal representative who is willing and capable of providing authorization for participation in the LSR
Exclusion Criteria
- •Patient who cannot be followed on the LATITUDE Patient Management system
- •Patient who is unable or unwilling to comply with the protocol requirements