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 |
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.
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.
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
sites
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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