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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Lead Externalization and Abrasion


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General
522 Number / Requirement Number PS120111 / PSS001
Current Plan Approved 02/22/2013
Study Name Lead Externalization and Abrasion
Root Document Number P950022/S014  P950022/S018  P950022/S024  P030054/S004  P030054/S018  P030054/S049  P950022/S042 
General Study Protocol Parameters
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.

Study Population Description Patients ≥ 18 years of age who meet inclusion/exclusion criteria have at least one market released lead implanted in time period

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.

Data Collection "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

"

Follow-up Visits and Length of Follow-up All patients will be followed every six months for three years.



Lead Externalization and Abrasion Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 08/22/2013 08/22/2013 On Time
one year report 02/22/2014 02/20/2014 On Time
18 month report 08/22/2014 08/25/2014 Overdue/Received
two year report 03/24/2015 03/23/2015 On Time
three year report 02/22/2016    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD 20993-0002

Phone: (301) 796-7033
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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