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Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Medtronic Cardiac Rhythm Disease Management.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00824915
First received: January 16, 2009
Last updated: July 30, 2009
Last verified: July 2009
History of Changes
  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:

MedlinePlus related topics: Shock
U.S. FDA Resources

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 ]

Estimated Enrollment: 3873
Study Start Date: August 2008
Estimated Primary Completion Date: August 2010 (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: RVLIA Trial Leader, Medtronic, Inc.
ClinicalTrials.gov Identifier: NCT00824915     History of Changes
Other Study ID Numbers: MDT1623319
Study First Received: January 16, 2009
Last Updated: July 30, 2009
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 May 21, 2013