Ignite Creation Date:
2024-05-05 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 9:56 AM
Study NCT ID:
NCT00773539
Status:
UNKNOWN
Last Update Posted:
2008-10-16
First Post:
2008-10-14
Brief Title:
A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
Sponsor:
Herz-Zentrums Bad Krozingen
Organization:
Herz-Zentrums Bad Krozingen
Study Overview
Official Title:
Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRYO-RF
Brief Summary:
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 activationoverall 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
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 activationoverall 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None