NCT00621621

CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tachycardia, Atrioventricular Nodal Reentry

Interventions

Type	Name	Description
DEVICE	Freezor® Cardiac Cryoablation Catheter CryoConsole System	cryoablation

Timeline

• Start date: 2006-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2008-02-22
• Last updated: 2018-10-16
• Results posted: 2015-04-23

Locations

4 sites across 1 country: United States