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Longitudinal Surveillance Registry (LSR)

This study has been terminated.
Sponsor:
Information provided by:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT00636272
First received: March 7, 2008
Last updated: August 14, 2008
Last verified: August 2008
  Purpose

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
Heart Failure
Sudden Cardiac Death

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Surveillance Registry

Further study details as provided by Boston Scientific Corporation:

Estimated Enrollment: 2500
Study Start Date: March 2008
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patient who are or will be implanted with a LATITUDE-enabled pulse generator (ICD or CRT-D).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636272

Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Study Director: Boston Scientific Boston Scientific Corporation
  More Information

No publications provided

Responsible Party: Boston Scientific CRM
ClinicalTrials.gov Identifier: NCT00636272     History of Changes
Other Study ID Numbers: CR-CA-011608-T
Study First Received: March 7, 2008
Last Updated: August 14, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
ICD
CRT-D

Additional relevant MeSH terms:
Death, Sudden, Cardiac
Heart Failure
Cardiovascular Diseases
Death
Death, Sudden
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014