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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database
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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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NaviStar Study


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General
Study Status Completed
Application Number /
Requirement Number		 P040036 / PAS001
Date Original Protocol Accepted 08/11/2006
Date Current Protocol Accepted 08/11/2006
Study Name NaviStar Study
Device Name NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, observational, multi-site, non-randomized, single arm study (please expand). This study is designed to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease.
Study Population All patients who are considered for a radio frequency ablation procedure for drug refractory sustained, monomorphic or incessant ventricular tachycardia associated with coronary artery disease and who are eligible for treatment by a study investigator are to be screened, and then included in the study if they meet the inclusion and exclusion criteria.
Sample Size 249 total subjects and 224 evaluable subjects, 18 sites
Key Study Endpoints Endpoints include: 1) One-year all cause mortality, 2) Cardiovascular-specific adverse event at one week, 3) cardiac perforation, 4) pericardial effusion with hemodynamic compromise, 5) pulmonary embolus, 6) complete heart block, 7) stroke, 8) acute myocardial infarction, 9) new acute severe mitral or aortic regurgitation, 10) deep venous thrombosis, arterial dissection or injury that requires surgical treatment, and 11) death.
Follow-up Visits and Length of Follow-up Follow-up period will be three years, with follow-up visits every 6 months.


NaviStar Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
3 month report 11/10/2006 12/01/2006 Overdue/Received
6 month report 02/09/2007 03/01/2007 Overdue/Received
9 month report 05/11/2007 05/03/2007 On Time
1 year report 08/11/2007 08/06/2007 On Time
15 month report 11/10/2007 11/09/2007 On Time
18 month report 02/09/2008 02/11/2008 Overdue/Received
21 month report 05/10/2008 05/09/2008 On Time
2 year report 08/10/2008 08/08/2008 On Time
27 month report 11/09/2008 11/07/2008 On Time
30 month report 02/08/2009 02/06/2009 On Time
33 month report 05/10/2009 05/08/2009 On Time
3 year report 08/10/2009 08/07/2009 On Time
39 month report 11/10/2009 11/09/2009 On Time
42 month report 02/08/2010 02/05/2010 On Time
4 year report 08/10/2010 08/10/2010 On Time
5 year report 08/10/2011 08/08/2011 On Time
6 year report 08/09/2012 08/03/2012 On Time
final report 11/22/2013 11/22/2013 On Time


Contact Us
Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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