CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,216 enrolled
Drug / intervention
Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leadsdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT01507987N/ACompleted
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St.Jude Medical Cardiac Lead Assessment Study

Abbott Medical Devices·observational·Posted Jan 11, 2012·Updated Aug 23, 2021

In Brief

An observational study evaluating Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads for Externalized Conductors and 2 related conditions. Completed, enrolled 2,216 participants across 45 sites in 3 countries.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsExternalized Conductors, Visual Lead Anomalies, Electrical Dysfunction
CountriesCanada, Japan, United States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 11, 2012
Enrollment StartMar 1, 2013
Primary CompletionJun 1, 2019
Study CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.5 years ago

Interventions

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

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