NCT00636272

Longitudinal Surveillance Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 2,500 (estimated)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Conditions

• Heart Failure
• Sudden Cardiac Death

Timeline

• Start date: 2008-03-01
• First posted: 2008-03-14
• Last updated: 2008-08-18