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Enhanced Surveillance of RV Lead Integrity Alert (RVLIA) (RVLIA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824915
First Posted: January 19, 2009
Last Update Posted: June 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure
  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)

Further study details as provided by Medtronic Cardiac Rhythm and Heart Failure:

Primary Outcome Measures:
  • Sensitivity of the LIA algorithm [ Time Frame: 2 years ]
  • Positive predictive value of the LIA algorithm [ Time Frame: 2 years ]
  • Number of false positives per patient-year of the LIA algorithm [ Time Frame: 2 years ]
  • 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) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824915


Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
Study Chair: RVLIA Trial Leader Medtronic
  More Information

Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT00824915     History of Changes
Other Study ID Numbers: MDT1623319
First Submitted: January 16, 2009
First Posted: January 19, 2009
Last Update Posted: June 26, 2013
Last Verified: June 2013

Keywords provided by Medtronic Cardiac Rhythm and Heart Failure:
Lead Integrity Algorithm