A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
NCT ID: NCT00773539
Last Updated: 2008-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
78 participants
INTERVENTIONAL
2008-07-31
2009-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
PVI using an open irrigated tip catheter
transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
2
PVI using a closed irrigated tip catheter
transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
3
PVI using a cryoballoon
transseptal PVI using the cryoballoon from CRYOCATH
Interventions
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PVI using an open irrigated tip catheter
transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
PVI using a closed irrigated tip catheter
transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
PVI using a cryoballoon
transseptal PVI using the cryoballoon from CRYOCATH
Eligibility Criteria
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Inclusion Criteria
* Symptomatic drug refractory (more than 2 antiarrhythmic drugs) paroxysmal or persistent AF
* Documentation of AF on 12 lead ECG and/ or Holter
* Left atrium of less than 55 mm
* Informed consent signed by the patient
Exclusion Criteria
* Contra-indication for heart catheterisation
* Cardioversion for AF during the 2 weeks before the procedure
18 Years
75 Years
ALL
No
Sponsors
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CryoCath Technologies Inc.
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Herz-Zentrums Bad Krozingen
OTHER
Responsible Party
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Herz-Zentrum Bad Krozingen
Locations
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Herz-Zentrum
Bad Krozingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Thomas Arentz, MD
Role: primary
Reinhold Weber, MD
Role: backup
References
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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.
Other Identifiers
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CRYO-BAD-KROZ
Identifier Type: -
Identifier Source: org_study_id