We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00824915
Recruitment Status : Completed
First Posted : January 19, 2009
Last Update Posted : June 26, 2013
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Shock

Study Design

Study Type : Observational
Actual Enrollment : 1779 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Surveillance of RV Lead Integrity Alert (RVLIA)
Study Start Date : August 2008
Primary Completion Date : February 2011
Study Completion Date : February 2011
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Sensitivity of the LIA algorithm [ Time Frame: 2 years ]
  2. Positive predictive value of the LIA algorithm [ Time Frame: 2 years ]
  3. Number of false positives per patient-year of the LIA algorithm [ Time Frame: 2 years ]
  4. 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) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Posted: January 19, 2009    Key Record Dates
Last Update Posted: June 26, 2013
Last Verified: June 2013

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