A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Conditions
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Atrial Fibrillation Ablation

Intervention / Treatment
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* Procedure: PVI using an open irrigated tip catheter
* Procedure: PVI using a closed irrigated tip catheter
* Procedure: PVI using a cryoballoon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 75 years 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: Previous Ablation or operation for AF Contra-indication for heart catheterisation Cardioversion for AF during the 2 weeks before the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Procedure: PVI using an open irrigated tip catheter<br>* transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block<br>|
| Active Comparator: 2<br> | Procedure: PVI using a closed irrigated tip catheter<br>* transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block<br>|
| Active Comparator: 3<br> | Procedure: PVI using a cryoballoon<br>* transseptal PVI using the cryoballoon from CRYOCATH<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF. |  | before, during and 6 months after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, pulmonary veins, ablation