• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

  • Print
  • Share
  • E-mail
-
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

 

 

 

 

            

ADVANCE ASO


Suggest Enhancement / Report Issue | Export to ExcelExport to Excel
General
522 Number / Requirement Number PS130046 / PSS001
Current Plan Approved 06/20/2014
Study Name ADVANCE ASO
Root Document Number P000039 
General Study Protocol Parameters
Study Population Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21, Subject enrollment milestones not met
Detailed Study Protocol Parameters
Study Design Description Patients indicated for ASD closure with echocardiographic evidence of ostium secundum atrial septal defect.

Study Population Description Patients indicated for ASD closure with echocardiographic evidence of ostium secundum atrial septal defect.

Sample Size This study will enroll 8,000 subjects from up to 450 in the US.

Data Collection Independent Erosion Board-Any potential erosions will be reviewed by the Erosion Board to confirm an erosion event occurred according to pre-defined procedures.Echocardiography Core Laboratory- Echocardiograms for all subjects in the analysis population (i.e., sub-cohort plus those with erosion events) will be reviewed and assessed by an Echocardiography Core Laboratory.Use of the term erosion as an endpoint in this study is limited to the perforation, laceration or penetration of the atrial septal defect occluder through adjacent cardiac structures. Acute procedural injury resulting in perforations or lacerations, with or without effusion and/or tamponade that are related to instrumentation or manipulation involving areas of the heart or aorta that are not in contact with the device should not be reported as an erosion. If the subject newly presents at any point in time with one or more of the signs or symptoms listed below an assessment should be conducted to determine if erosion has occurred as a result of the presence of an atrial septal defect occluder. Hemodynamic instability such as: Chest pain, Arrhythmia, Fainting, Shortness of breath. Diagnostic imaging, either echocardiography, CT scan, or MRI, should be done to assess the subject for the presence of erosion. Findings indicative of possible erosion include pericardial effusion, cardiac tamponade, extra-anatomic position of the device, or a fistula between the aorta and either atrium. Erosion due to the ASD occluder will only be confirmed upon autopsy or direct surgical visualization of the injury in a location of the atrium and/or aorta that is consistent with erosion.

Follow-up Visits and Length of Follow-up Subjects will be evaluated at Baseline, Implant, Pre-Discharge, 1-week, 1-month, 6-months, and 1-year.



ADVANCE ASO Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/19/2014 12/19/2014 On Time
1 yr report 06/20/2015 06/18/2015 On Time
18 month report 12/19/2015    
2 yr report 06/19/2016    
3 yr report 06/19/2017    
4 yr report 06/19/2018    


  • 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
-
-