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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS120111 / PSS001 |
| Date Original Plan Accepted |
02/22/2013
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| Date Current Plan Accepted |
12/18/2015
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| Study Name |
Lead Externalization and Abrasion
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| Device Name |
Riata, quicksite, quickflex, durata
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| Root Document Number |
P950022/S014
P950022/S018
P950022/S024
P030054/S004
P030054/S018
P030054/S049
P950022/S042
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| General Study Protocol Parameters |
| Study Design |
Retrospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This study is a prospective, non-randomized, multi-center, international post market study that will estimate the prevalence and incidence of externalized conductors (as evidenced by imaging) and the risk of progression to electrical dysfunction in a large series of ICD/ CRTD/CRT-P devices containing one or more of the following SJM leads: Riata/Riata ST silicone leads, Durata leads, QuickSite/QuickFlex CRT leads.
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| Study Population |
Patients greater than or equal to 18 years of age who meet inclusion/exclusion criteria have at least one market released lead implanted in time period
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| Sample Size |
A minimum of 1500 leads listed above will be enrolled at up to 50 sites. This will comprise a minimum of 300 leads in the Riata lead group and a minimum of 200 leads in the Riata ST lead group to make a combined total of at least 500 Riata and Riata ST silicone leads. The study will also include at least 500 leads in, the QuickSite/QuickFlex and Durata lead groups.
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| Key Study Endpoints |
"Primary outcome measures:
1. The prevalence of electrical dysfunction in the Riata/Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158), and Durata leads.
2. The prevalence of externalized conductors by imaging in the Riata/Riata ST, QuickSite/ QuickFlex (1056T, 1058T, 1156T, 1158), and Durata leads.
3. 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, 1158) and Durata leads.
4. The annual hazard rate of lead electrical dysfunction (from enrollment) conditional on implant year in the Riata/Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158), and Durata leads.
5. The annual hazard rate of new cases of externalized conductors evidenced by imaging (from enrollment), by year of initial implant in the Riata/Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158), and Durata leads.
6. 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, 1158), and Durata leads.
7. Prevalence of other insulation anomalies* in returned leads, by year of initial implant in the Riata/Riata ST, QuickSite/QuickFlex (1056T, 1058T, 1156T, 1158), and Durata 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 full thickness breach of the outer insulation and/or the internal silicone lumen tubing, but the conductor cable is contained within the lead body diameter.
Secondary outcome measures:
1. Time from enrollment to externalized conductors evidenced by imaging, by year of initial implant.
2. Time from enrollment to of other visual lead anomalies (evidenced by imaging), by year of initial implant.
3. Time from enrollment to electrical dysfunction, by year of implant
4. Time from externalized conductors evidenced by imaging to electrical dysfunction, by year of initial implant
5. Time from other visual lead anomalies by each lead subcategory to electrical dysfunction, by year of initial implant
6. Adverse Event rate through 30 days post-intervention for lead (e.g. extraction, abandonment, revision, other)
7. Time from externalized conductors to clinical intervention
8. Time from other visual lead anomalies by each subcategory to clinical intervention
9. 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
10. Comparison of patients with electrical dysfunction to those without electrical dysfunction"
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| Follow-up Visits and Length of Follow-up |
All patients will be followed every six months for three years.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
2216
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| Actual Number of Sites Enrolled |
45
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| Recommendations for Labeling Changes |
FDA recommends that the sponsor update the labeling for these devices to reflect the long-term data from the 522 Study.
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