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GUIDANCE DOCUMENT

Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter Guidance for Industry and FDA Staff August 2008

Final

Clinical Study Designs for Catheter Ablation Devices for Treatment of Atrial Flutter

Docket Number:
1678
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This guidance addresses the use of a randomized clinical trial (RCT) approach in designing clinical studies for catheter ablation devices for the treatment of atrial flutter. The first several premarket approval (PMA) applications approved for the treatment of atrial flutter relied on clinical data from single-arm trials because no devices were approved for treatment of atrial flutter. Recently approved IDE studies and PMA applications have used the option of a RCT given the availability of PMA-approved ablation catheters indicated for treatment of atrial flutter. This guidance provides recommendations about the clinical study designs that rely on a RCT.


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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 1678.