Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00824915

Acronym

RVLIA

Enrollment

1779

Registered

2009-01-19

Start date

2008-08-31

Completion date

2011-02-28

Last updated

2018-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shock

Keywords

Lead Integrity Algorithm

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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,

Design outcomes

Primary

Measure	Time frame
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)

Outcome results