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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

January 16, 2009
July 30, 2009
August 2008
August 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • To estimate the sensitivity of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To estimate the positive predictive value of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To estimate the number of false positives per patient-year of the LIA algorithm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To estimate the 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 ]
Complete list of historical versions of study NCT00824915 on ClinicalTrials.gov Archive Site
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Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with a confirmed Lead Integrity Algorithm download with a device download within the open and closed date of data collection
Shock
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3873
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August 2010   (final data collection date for primary outcome measure)

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,
Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00824915
MDT1623319
No
RVLIA Trial Leader, Medtronic, Inc.
Medtronic Cardiac Rhythm Disease Management
Not Provided
Study Chair: RVLIA Trial Leader Medtronic
Medtronic Cardiac Rhythm Disease Management
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP