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St.Jude Medical Cardiac Lead Assessment Study (SJM CLAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01507987
First received: January 6, 2012
Last updated: August 27, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Time from externalized conductors to clinical intervention [ Time Frame: This outcome is assessed from enrollment till the course of 3 years of follow-up ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2487
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507987

Contacts
Contact: Grant Kim, B.S. 8184933147 gkim@sjm.com
Contact: Vashtie Bachan 8184934282 vbachan@sjm.com

Locations
United States, Ohio
The Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Mark Niebauer, MD    216-444-3160    niebaum@ccf.org   
Principal Investigator: Mark Niebauer, MD         
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01507987     History of Changes
Other Study ID Numbers: CRD-619, CRD-619
Study First Received: January 6, 2012
Last Updated: August 27, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 24, 2014