NCT01507987

St.Jude Medical Cardiac Lead Assessment Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,216 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The objective of this study was to determine the prevalence and incidence of externalized conductors and other visual lead anomalies (as evidenced by imaging) and the risk of progression to electrical dysfunction in subjects with one or more of the following St. Jude Medical (SJM) cardiac leads: Riata leads, Riata ST leads, Durata and/or QuickSite/QuickFlex Cardiac Resynchronization Therapy (CRT) leads.

Conditions

• Externalized Conductors
• Visual Lead Anomalies
• Electrical Dysfunction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-03-01
• Primary completion: 2019-06-01
• Completion: 2019-09-01
• First posted: 2012-01-11
• Last updated: 2021-08-23
• Results posted: 2021-08-23

Locations

45 sites across 3 countries: United States, Canada, Japan