CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:10/18/2018
Start Date:December 2006
End Date:December 2013

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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.

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.

Inclusion Criteria:

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:

1. Patients with a clinical history of AVNRT who are referred for ablation.

2. Patients willing to provide written informed consent.

Post-EPS inclusion criteria:

1. Patients with EPS-documented AVNRT

Exclusion Criteria:

ANY of the following is regarded as a criterion for excluding a subject from the study:

1. Patients with any pre-existing AV block.

2. Patients with known cryoglobulinemia
We found this trial at
4
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Minneapolis, Minnesota 55407
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Minneapolis, MN
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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