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St.Jude Medical Cardiac Lead Assessment Study

NCT01507987 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2216

Last updated 2021-08-23

Study results available
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Summary

The Cardiac Lead Assessment Study (CLAS) is designed as a prospective, non-randomized, multi-center, international postmarket surveillance study under 522 Order PS120111 (August 16, 2012).

Conditions

  • Externalized Conductors
  • Visual Lead Anomalies
  • Electrical Dysfunction

Interventions

DEVICE

Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads

Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010 Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2019-06-30
Completion
2019-09-30

Countries

  • United States
  • Canada
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01507987 on ClinicalTrials.gov