A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Phase 4

• Conditions: Atrial Fibrillation Ablation
• Interventions: Procedure: PVI using an open irrigated tip catheter; Procedure: PVI using a closed irrigated tip catheter; Procedure: PVI using a cryoballoon

• Registration Number: NCT00773539
• Lead Sponsor: Herz-Zentrums Bad Krozingen

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 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

Not available

Study Timeline

• Study Start: 2008-07
• Status Verified: 2008-10
• Study First Submitted: 2008-10-14
• Study First Submitted QC: 2008-10-14
• Last Update Submitted: 2008-10-14
• Study First Posted: 2008-10-16
• Last Update Posted: 2008-10-16
• Primary Completion: 2009-02
• Study Completion: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PVI using an open irrigated tip catheter	-
2	PVI using a closed irrigated tip catheter	-
3	PVI using a cryoballoon	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF.	before, during and 6 months after procedure

Trial Locations

Locations (1)

Herz-Zentrum; 🇩🇪 Bad Krozingen, Germany