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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Cryocor Ablation PAS


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General
Application Number P050024 / PAS001
Current Plan Approved 03/13/2008
Study Name Cryocor Ablation PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a two armed observational study. The sponsor states sequential subjects who do not meet the exclusion criteria are enrolled into the study from a registry of patients treated for right atrial flutter with the CryoCor Cardiac Cryoablation System (study subjects) or approved radiofrequency catheter (controls). Enrollment will be sequential for eligible subjects, except that when the ratio of patients in the control arm to patients in the study arm exceeds 4:1, enrollment in the control arm will temporarily cease until an equal number of subjects have been enrolled in the study arm.
Study Population Description Sequential subjects who do not meet the exclusion criteria are enrolled into the study from a registry  of patients treated for right atrial flutter with the CryoCor Cardiac Cryoablation System (study subjects) or approved radiofrequency catheter (controls). Enrollment will be sequential for eligible subjects, except that when the ratio of patients in the control arm to patients in the study arm exceeds 4:1, enrollment in the control arm will temporarily cease until an equal number of subjects have been enrolled in the study arm.
Sample Size 325 pattients from 30 sites.
Data Collection Procedure-related adverse events within 7 days of procedure; 12 month atrial flutter recurrence free rate.
Follow-up Visits and Length of Follow-up A clinical assessment for adverse events is scheduled at 7 days post-procedure. After that, patients are contacted by phone at 3, 6, and 12 months post-procedure to assess the patient for adverse events and recurrence of atrial flutter.
Final Study Results
Interim Safety Information None available. Study was terminated before it began.




Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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