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St.Jude Medical Cardiac Lead Assessment Study (CLAS)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01507987
First Posted: January 11, 2012
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. Jude Medical
  Purpose

The objectives of the study are:

  1. To determine the prevalence of externalized conductors at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
  2. To determine the prevalence of other visual lead anomalies (fracture, subclavian crush, kink, broken filars on a shocking coil and other irregularities) by each subcategory at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
  3. To determine the prevalence of electrical dysfunction at enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
  4. To determine the incidence of externalized conductors after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
  5. To determine the incidence of other visual lead anomalies by each subcategory after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads
  6. To determine the incidence of electrical dysfunction after enrollment in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex® and Durata® leads.
  7. To evaluate the 30-day adverse event rate associated with lead revision procedures (include lead extractions or abandonments with or without lead replacement) in Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads
  8. To determine the prevalence of "other insulation anomalies" in "returned leads" for Riata®, Riata® ST Silicone, QuickSite®/QuickFlex®, and Durata® families of leads. "Other insulation anomalies" include any of the following:

    • Internal abrasion short under RV shock coil
    • Internal abrasion short under SVC shock coil
    • Exposed conductors defined as a breach of the outer insulation
    • Breach of the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter.

Condition
Prevalence of Externalized Conductors and Other Visual Lead Anomalies in Certain Family of High Voltage and CRT Leads

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: St.Jude Medical Cardiac Lead Assessment Study

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • The prevalence of electrical dysfunction in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ]
  • The prevalence of externalized conductors in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ]
  • The prevalence of other visual lead anomalies by each subcategory (fracture, kink, subclavian crush, other irregularities) in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed at enrollment and over the course of 3 years of follow-up ]
  • The annual hazard rate of lead electrical dysfunction (from enrollment) conditional on implant year in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • The annual hazard rate of new cases of externalized conductors (from enrollment), by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • The annual hazard rate of new cases of other visual lead anomalies by each subcategory (from enrollment), by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Prevalence of "other insulation anomalies" in "returned leads" by year of initial implant in the Riata, Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158T) and Durata leads. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]

Secondary Outcome Measures:
  • Time from enrollment to externalized conductors by year of initial implant [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from enrollment to other visual lead anomalies (evidenced by imaging) by year of initial implant and each subcategory. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from enrollment to electrical dysfunction, by year of implant [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from externalized conductors to electrical dysfunction, by year of initial implant. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from other visual lead anomalies by each lead subcategory to electrical dysfunction, by year of initial implant. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other). [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from externalized conductors to clinical intervention [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Time from other visual lead anomalies by each subcategory to clinical intervention. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Comparison of patients with lead compromise as evidenced by imaging (includes externalized conductors and other visual lead anomalies by each subcategory) to those without lead compromise. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]
  • Comparison of patients with electrical dysfunction to those without electrical dysfunction. [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ]

Enrollment: 2215
Study Start Date: March 2013
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients that have a market released St. Jude Medical Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy - Defibrillator (CRT-D) already implanted and also have at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted.
Criteria

Inclusion Criteria:

  1. Patient has a market released SJM ICD, CRT-D or CRT-P already implanted.
  2. Patient has at least one market released Riata/ Riata ST/QuickSite/QuickFlex/Durata already implanted in which the lead model number and lead implant date is indicated in Table 1.
  3. Have the ability to provide informed consent for study participation and be willing to comply with the prescribed evaluations as detailed in this study plan.
  4. Are 18 years or above

Exclusion Criteria:

  1. Patient is currently pregnant.
  2. Enrolled or intend to participate in a clinical drug and/or device study, which could confound the results of this trial as determined by SJM, during the course of this clinical study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01507987


Locations
United States, Ohio
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
St. Jude Medical
  More Information

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01507987     History of Changes
Other Study ID Numbers: 60039775/K
CRD-619 ( Other Identifier: St. Jude Medical )
First Submitted: January 6, 2012
First Posted: January 11, 2012
Last Update Posted: July 7, 2017
Last Verified: June 2017

Keywords provided by St. Jude Medical:
Externalized Conductors