A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Atrial Fibrillation Ablation Clinical Trial

— CRYO-RF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00773539
• Other study ID #: CRYO-BAD-KROZ
• Status: Recruiting
• Phase: Phase 4
• First received: October 14, 2008
• Last updated: October 14, 2008
• Start date: July 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2008
• Source: Herz-Zentrums Bad Krozingen
• Contact: Thomas Arentz, MD
• Phone: 004976334020
• Email: thomas.arentz[@]herzzentrum.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 78
• Est. completion date: August 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation Ablation

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Germany	Herz-Zentrum	Bad Krozingen

Sponsors (3)

Lead Sponsor	Collaborator
Herz-Zentrums Bad Krozingen	Boston Scientific Corporation, CryoCath Technologies Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Secondary	Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF.		before, during and 6 months after procedure	Yes