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St. Jude Medical Cardiac Lead Assessment Study (CLAS)
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Sample details

The objective of CLAS 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. All participants within this cohort had one of the specified devices implants, including Riata leads or an SJM Implantable Cardioverter Defibrillator (ICD). A total of 2,847 leads were studied among the participants, including 670 Riata, 458 Riata ST, 982 Durata, and 737 QuickSite/QuickFlex leads. The average age of the sample was 67.0 years, and 27.1% were female. The participants were followed for three years.

Study design
Cohort - clinical

Number of participants at first data collection

2,216 (participants)

Age at first data collection

≥ 18 years (participants)

Participant year of birth

Varied (participants)

Participant sex
All

Representative sample at baseline?
No

Sample features

Patients and clinical populations
Dataset details
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Countries

Canada, Japan, United States of America

Year of first data collection

2013

Primary Institutions

St. Jude Medical (now known as Abbott Medical Devices)

Links

clinicaltrials.gov/show/NCT01507987

Funders

Abbott

Ongoing?
No

Data types collected

dataLinkage
Quantitative data collection
  • Interview – face-to-face
  • Physical or biological assessment (e.g. blood, saliva, gait, grip strength, anthropometry)
Qualitative data collection
  • None
Neuroimaging data collection
  • None
Linked or secondary data
  • Healthcare data
Features

Engagement

  • None
  • Keywords

    Cardiovascular health and disease
    Defibrillator
    Medical conditions
    Pacemakers
    Treatment experiences and outcomes
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