A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy (CRYO-RF)
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|ClinicalTrials.gov Identifier: NCT00773539|
Recruitment Status : Unknown
Verified October 2008 by Herz-Zentrums Bad Krozingen.
Recruitment status was: Recruiting
First Posted : October 16, 2008
Last Update Posted : October 16, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Ablation||Procedure: PVI using an open irrigated tip catheter Procedure: PVI using a closed irrigated tip catheter Procedure: PVI using a cryoballoon||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||78 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||February 2009|
|Estimated Study Completion Date :||August 2009|
|Active Comparator: 1||
Procedure: PVI using an open irrigated tip catheter
transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
|Active Comparator: 2||
Procedure: PVI using a closed irrigated tip catheter
transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
|Active Comparator: 3||
Procedure: PVI using a cryoballoon
transseptal PVI using the cryoballoon from CRYOCATH
- 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) [ Time Frame: 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. [ Time Frame: before, during and 6 months after procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773539
|Contact: Thomas Arentz, MDfirstname.lastname@example.org|
|Contact: Dietmar Trenkemail@example.com|