Longitudinal Surveillance Registry

NCT00636272 | Terminated DMC

• 1 other identifier: CR-CA-011608-T
• Study Type: observational
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure; Sudden Cardiac Death

Keywords

ICD; CRT-D

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient who cannot be followed on the LATITUDE Patient Management system
• Patient who is unable or unwilling to comply with the protocol requirements

Sponsors & Collaborators

• Boston Scientific Corporation: lead

MeSH Terms

Conditions

Heart Failure; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Boston Scientific

  Boston Scientific Corporation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: March 1, 2008
• Last Updated: August 18, 2008

Record last verified: 2008-08