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NCT00824915 Clinical Trial

Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Shock Clinical Trial

— RVLIA  

Official title:
Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00824915
Other study ID # MDT1623319
Secondary ID
Status Completed
Phase N/A
First received January 16, 2009
Last updated February 28, 2018
Start date August 2008
Est. completion date February 2011

Study information
Verified date February 2018
Source Medtronic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose is to prospectively monitor the performance of the RV Lead Integrity Alert (LIA) upon commercial release.

Recruitment information / eligibility
Status Completed
Enrollment 1779
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medtronic

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity of the LIA algorithm 2 years
Primary Positive predictive value of the LIA algorithm 2 years
Primary Number of false positives per patient-year of the LIA algorithm 2 years
Primary 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)
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