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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014