NCT00621621|CompletedPhase 4Results
CryoCath Freezor CryoAblation Catheter System (CRYOFACTS)
PS-010
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Sponsor study identifier
interventional
105
1 country
4
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
February 13, 2008
Actual (reported)February 22, 2008
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)April 23, 2015
Actual (reported)Device or Procedure Related AV Block Persistent Through Discharge From Hospital.
After 250 subjects have been enrolled.
AV Block That Requires the Insertion of a Permanent Pacemaker: Defined as the Insertion of a Permanent Pacemaker, as Assessed During Defined Study Follow up.
After 250 subjects have been enrolled.
Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.
This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
cryoablation
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
University of Nebraska Medical Center
Omaha, Nebraska, 63198-7835, United States
Columbia University Medical Center and the New York Presbyterian Hospital
New York, New York, 10032, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Friedman PL, Dubuc M, Green MS, Jackman WM, Keane DT, Marinchak RA, Nazari J, Packer DL, Skanes A, Steinberg JS, Stevenson WG, Tchou PJ, Wilber DJ, Worley SJ. Catheter cryoablation of supraventricular tachycardia: results of the multicenter prospective "frosty" trial. Heart Rhythm. 2004 Jul;1(2):129-38. doi: 10.1016/j.hrthm.2004.02.022.
Slow enrollment in the trial showed limited the amount of available data. Detailed subject data from the published literature was not available.
John Lehmann, MD, MPH
Lehmann Consulting
105 participants (actual enrollment reported by the registry).
First Submitted
February 13, 2008
First Posted
February 22, 2008
Study Start
December 2006
Date type not reportedThis date has not been verified as actual or estimated.
Comparative Study Between Cryoablation and Radiofrequency Ablation in the Treatment of Supraventricular Tachycardia
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
October 16, 2018
Results First Posted
April 23, 2015
Record last verified: 2018-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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