Status:
TERMINATED
Longitudinal Surveillance Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Heart Failure
Sudden Cardiac Death
Eligibility:
All Genders
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 availabl...
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 ...
Eligibility Criteria
Inclusion
- 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
- Patient who cannot be followed on the LATITUDE Patient Management system
- Patient who is unable or unwilling to comply with the protocol requirements
Key Trial Info
Start Date :
March 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00636272
Start Date
March 1 2008
Last Update
August 18 2008
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