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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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CryoFACTS


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General
Study Status Completed
Application Number /
Requirement Number		 P020045 / PAS001
Date Original Protocol Accepted 04/17/2003
Date Current Protocol Accepted 04/17/2003
Study Name CryoFACTS
Device Name 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives Observational single arm, non-randomized study and literature review
Study Population Adults referred for ablation of AVNRT.
Sample Size 75 subjects from 10-15 sites
Subjects from medical literature
Key Study Endpoints Device or procedure-related A-V block that persists through discharge;

Device or procedure-related A-V block that persists through discharge and requires the insertion of a permanent pacemaker;

Acute procedural success, defined as absence of recurrence and non- inducibility of the targeted antrioventricular nodal reentrant tachycardia.
Follow-up Visits and Length of Follow-up 3 months
Discharge and three months.
Interim or Final Data Summary
Interim Results Of the 54 participants, none have had device or procedure related AV block persistent through discharge from the hospital.
Actual Number of Patients Enrolled 75 in study
705 from literature
Actual Number of Sites Enrolled 4
Patient Follow-up Rate 100%
Final Safety Findings Of the 75 participants, none have had AV block persistent through
discharge from the hospital (95% CI = 0-4.8%). There were no subject deaths.

Study and literature combined -
Permanent AV block: 0% (95% CI=0% - 0.5%)
Final Effect Findings Acute procedural success has been reported in 71 of the 74 participants (95.9%) for whom ablation was performed.

Study and literature combined -
Acute procedural success: 93.5% (95% CI=91.5% - 95.1%)
Study Strengths & Weaknesses Both safety and effectiveness objectives were met by a good margin.
Literature review suffers from potential lack of representativeness.
Recommendations for Labeling Changes None


CryoFACTS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
45 Month PAS report 02/11/2008 02/11/2008 On Time
Annual Report 04/08/2009 07/08/2009 Overdue/Received
Annual report 04/08/2010 05/07/2010 Overdue/Received
7 year report (84 month) 04/28/2011 04/28/2011 On Time
96 month report (8 year) 04/18/2012 04/16/2012 On Time
unplanned report 12/10/2012 12/10/2012 On Time
9 year report-FINAL 04/18/2013 04/09/2013 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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