Status:
COMPLETED
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Tachycardia, Atrioventricular Nodal Reentry
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 proc...
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 allow...
Eligibility Criteria
Inclusion
- 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:
- 1\. Patients with EPS-documented AVNRT
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT00621621
Start Date
December 1 2006
End Date
December 1 2013
Last Update
October 16 2018
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States, 55407
2
University of Nebraska Medical Center
Omaha, Nebraska, United States, 63198-7835
3
Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York, United States, 10032
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195