Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
Completed
- Conditions
- Shock
- Registration Number
- NCT00824915
- Lead Sponsor
- Medtronic
- Brief Summary
The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1779
Inclusion Criteria
- Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort
Exclusion Criteria
- A device that does not support the Lead Integrity Algorithm,
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of the LIA algorithm 2 years Positive predictive value of the LIA algorithm 2 years Number of false positives per patient-year of the LIA algorithm 2 years Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock Event driven (analysis requires 50 events)
- Secondary Outcome Measures
Name Time Method