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Longitudinal Surveillance Registry (LSR)

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ClinicalTrials.gov Identifier: NCT00636272
Recruitment Status : Terminated
First Posted : March 14, 2008
Last Update Posted : August 18, 2008
Sponsor:
Information provided by:
Boston Scientific Corporation

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).

Condition or disease
Heart Failure Sudden Cardiac Death

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 Type : Observational
Estimated Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Surveillance Registry
Study Start Date : March 2008




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636272


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

Responsible Party: Boston Scientific CRM
ClinicalTrials.gov Identifier: NCT00636272     History of Changes
Other Study ID Numbers: CR-CA-011608-T
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: August 18, 2008
Last Verified: August 2008

Keywords provided by Boston Scientific Corporation:
ICD
CRT-D

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