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GUIDANCE DOCUMENT

Recommended Clinical Study Design for Ventricular Tachycardia Ablation May 1999

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Center 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.

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All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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