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Guidance Issuing OfficeCenter for Devices and Radiological Health
The use of cardiac ablation for the treatment of Ventricular Tachycardia raises many new questions of safety and effectiveness in comparison to the use of cardiac ablation for the treatment of Supraventricular Tachycardias. The following outline has been provided to aid sponsors in developing a protocol for the treatment of Ventricular Tachycardia. We have given you two study designs: non-randomized and randomized. In no way is this outline intended to be all inclusive of the necessary components for a clinical study. This outline was based on recommendations provided to the FDA by Circulatory System Devices Panel members and by comments offered by clinical investigators.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.