CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)

Completed · Phase 4

Conditions studied: Tachycardia, Atrioventricular Nodal Reentry

In brief

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.

Key facts

Study ID

NCT00621621

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

105

Starts

2006-12-01

Expected to finish

2013-12-01

Last updated by the study team

2018-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Some inclusion criteria can only be established during the electrophysiologic study (EPS); thus there are two groups of inclusion criteria.
• For inclusion in the study subjects must fulfill ALL of the following criteria:
• Pre-EPS inclusion criteria:
• Patients with a clinical history of AVNRT who are referred for ablation.
• Patients willing to provide written informed consent.
• Post-EPS inclusion criteria:
• Patients with EPS-documented AVNRT

You may not qualify if…

• ANY of the following is regarded as a criterion for excluding a subject from the study:
• Patients with any pre-existing AV block.
• Patients with known cryoglobulinemia

Where it is running

• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Columbia University Medical Center and the New York Presbyterian Hospital — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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