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CRYO-RF
Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
Sponsor study identifier
interventional
78
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Transvenous pulmonary vein (PV) isolation using radiofrequency energy is an effective treatment for atrial fibrillation (1-4). However, rare but potentially life threatening complications such as thromboembolism (5), PV stenosis (5-10), left atrium-oesophageal fistula (11) and inflammatory syndromes (12) have been described. In preliminary studies an alternate approach using cryoenergy induces less endothelial disruption/ thrombus formation (13), preserves the extra cellular matrix and creates lesions with well-delineated border zones (14). Therefore, cryoenergy seems to be the ideal form of energy to safely perform PV isolation. We therefore hypothesise that in the setting of PV isolation for the treatment of atrial fibrillation (AF) cryoenergy is less traumatic and therefore reduces systemic inflammatory responses compared to radiofrequency energy. 78 patients presenting with symptomatic intermittent or persistent AF will be randomised to PV isolation with either radiofrequency (26 patients open irrigated tip, 26 patients closed irrigated tip) or cryoenergy (26 patients with cryoballoon). Systemic markers of cell damage and inflammatory response (t-troponin, CK, CK-MB, vWF, PAI-1, micro particles, platelet activation/overall function, CRP, IL-6, IL-8, IL-10, TNF alpha, procalcitonin) will be monitored before, during and 48h after the procedure. Further endpoints include time to PV-isolation and procedure related complications. Six month clinical follow-up will focus on freedom from AF and cardiovascular events.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
October 14, 2008
Actual (reported)October 16, 2008
Actual (reported)February 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Changes of platelet function (number of patients with an increase of more than 100% in platelets positive for either P-selectin or activated GP IIb/IIIa)
before, at the end of intervention, 6, 24 and 48 hours later.
Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF.
before, during and 6 months after procedure
transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
Herz-Zentrum
Bad Krozingen, 79189, Germany
Jesel L, Arentz T, Herrera-Siklody C, Trenk D, Zobairi F, Abbas M, Weber R, Minners J, Toti F, Morel O. Do atrial differences in endothelial damage, leukocyte and platelet activation, or tissue factor activity contribute to chamber-specific thrombogenic status in patients with atrial fibrillation? J Cardiovasc Electrophysiol. 2014 Mar;25(3):266-70. doi: 10.1111/jce.12312. Epub 2013 Nov 22.
Herrera Siklody C, Arentz T, Minners J, Jesel L, Stratz C, Valina CM, Weber R, Kalusche D, Toti F, Morel O, Trenk D. Cellular damage, platelet activation, and inflammatory response after pulmonary vein isolation: a randomized study comparing radiofrequency ablation with cryoablation. Heart Rhythm. 2012 Feb;9(2):189-96. doi: 10.1016/j.hrthm.2011.09.017. Epub 2011 Sep 13.
First Submitted
October 14, 2008
First Posted
October 16, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2009
Estimated (date passed)transseptal PVI using the cryoballoon from CRYOCATH
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 16, 2008
Record last verified: 2008-10
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Source: ClinicalTrials.gov.
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