NCT00824915

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,779

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

2.5 years

First QC Date

January 16, 2009

Last Update Submit

February 28, 2018

Conditions

Shock

Keywords

Lead Integrity Algorithm

Outcome Measures

Primary Outcomes (4)

  • 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)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a confirmed Lead Integrity Algorithm download with a device download within the open and closed date of data collection

You may qualify if:

  • Lead Integrity Algorithm download; requires a Medtronic device that supports the LIA algorithm; requires an RV lead; selected as part of the identified cohort

You may not qualify if:

  • A device that does not support the Lead Integrity Algorithm,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • RVLIA Trial Leader

    Medtronic

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2009

First Posted

January 19, 2009

Study Start

August 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 2, 2018

Record last verified: 2018-02