Last updated on November 2017

Intracardiac Cryoablation for AtrioVentrIcular Nodal Reentrant Tachycardia (ICY/AVNRT)

Brief description of study

Intracardiac Cryoablation for AtrioVentrIcular Nodal Reentrant Tachycardia (ICY/AVNRT)

Detailed Study Description

ICY-AVNRT (Intracardiac CrYoablation for AtrioVentricular Nodal Reentrant Tachycardia), a prospective multi-center, non-randomized, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to demonstrate the safety and effectiveness of the Freezor® Xtra Cardiac CryoAblation Catheter for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (AVNRT) using an endocardial approach.

The Freezor Xtra is a flexible, steerable 7 French catheter with a 6 mm cryoablation tip. It is used in conjunction with the CryoConsole and related components. The CryoConsole provides comprehensive procedural information and control, as well as multiple hardware and software safety features. The tip of the Freezor Xtra cryocatheter catheter reaches cryoablation temperatures when refrigerant is injected from the CryoConsole to the tip of the catheter, freezing the adjacent tissue

Clinical Study Identifier: TX81453

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Recruitment Status: Closed

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