CryoCath Freezor CryoAblation Catheter System (CRYOFACTS) — PS-010  

Tachycardia, Atrioventricular Nodal Reentry Clinical Trial

Official title: CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Status Completed

Clinical Trial Summary

The purpose of this post approval study of heart block is to gather additional information regarding how often patients develop heart block (atrioventricular block) after having standard ablation procedure using cryotherapy with the Freezor™ catheter.

Clinical Trial Description

Due to the lack of enrollments for the trial. The FDA and Medtronic discussed the inclusion of data found from from published literature (external studies) to corroborate study endpoint. The FDA allowed this data and the study was closed. ;

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Atrioventricular Nodal Reentry

• NCT number: NCT00621621
• Study type: Interventional
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Status: Completed
• Phase: Phase 4
• Start date: December 2006
• Completion date: December 2013