Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00824915
First received: January 16, 2009
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

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


Condition
Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

Resource links provided by NLM:


Further study details as provided by Medtronic Cardiac Rhythm Disease Management:

Primary Outcome Measures:
  • Sensitivity of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Positive predictive value of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of false positives per patient-year of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 1779
Study Start Date: August 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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

Criteria

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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824915

Sponsors and Collaborators
Medtronic Cardiac Rhythm Disease Management
Investigators
Study Chair: RVLIA Trial Leader Medtronic
  More Information

No publications provided

Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00824915     History of Changes
Other Study ID Numbers: MDT1623319
Study First Received: January 16, 2009
Last Updated: June 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Cardiac Rhythm Disease Management:
Lead Integrity Algorithm

Additional relevant MeSH terms:
Shock
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014