Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

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

Completed

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Key information

Conditions

Shock Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

Sensitivity of the LIA algorithm

Time frame: 2 years
Positive predictive value of the LIA algorithm

Time frame: 2 years
Number of false positives per patient-year of the LIA algorithm

Time frame: 2 years
Reduction in the percent of patients with the LIA algorithm with an RV lead fracture who receive at least one inappropriate shock

Time frame: Event driven (analysis requires 50 events)

Sponsors and collaborators

Lead sponsor

Medtronic

Industry

Registry information

Acronym: RVLIA

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jan 19, 2009
Registry last updated: Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed