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Sponsored by: |
Boston Scientific Corporation |
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Information provided by: | Boston Scientific Corporation |
ClinicalTrials.gov Identifier: | NCT00636272 |
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).
Condition |
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Heart Failure Sudden Cardiac Death |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Longitudinal Surveillance Registry |
Estimated Enrollment: | 2500 |
Study Start Date: | March 2008 |
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
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patient who are or will be implanted with a LATITUDE-enabled pulse generator (ICD or CRT-D).
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Boston Scientific CRM ( Boston Scientific CRM ) |
Study ID Numbers: | CR-CA-011608-T |
Study First Received: | March 7, 2008 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00636272 History of Changes |
Health Authority: | United States: Institutional Review Board |
ICD CRT-D |
Death Heart Failure Heart Diseases |
Death, Sudden Heart Arrest Death, Sudden, Cardiac |
Death Heart Failure Pathologic Processes Heart Diseases |
Death, Sudden Heart Arrest Cardiovascular Diseases Death, Sudden, Cardiac |