A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy - Full Text View

Sponsors and Collaborators:	Herz-Zentrums Bad Krozingen CryoCath Technologies Inc. Boston Scientific Corporation
Information provided by:	Herz-Zentrums Bad Krozingen
ClinicalTrials.gov Identifier:	NCT00773539

Purpose

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	Intervention	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 IV

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

Further study details as provided by Herz-Zentrums Bad Krozingen:

Primary Outcome Measures:

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. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF. [ Time Frame: before, during and 6 months after procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	78
Study Start Date:	July 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Procedure: PVI using an open irrigated tip catheter transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
2: Active Comparator	Procedure: PVI using a closed irrigated tip catheter transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
3: Active Comparator	Procedure: PVI using a cryoballoon transseptal PVI using the cryoballoon from CRYOCATH

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773539

Contacts

Contact: Thomas Arentz, MD	004976334020	thomas.arentz@herzzentrum.de
Contact: Dietmar Trenk	004976334020	dietmar.trenk@herzzentrum.de

Locations

Germany
Herz-Zentrum	Recruiting
Bad Krozingen, Germany, 79189
Contact: Thomas Arentz, MD 004976334020 thomas.arentz@herzzentrum.de
Contact: Reinhold Weber, MD 004976334020 reinhold.weber@herzzentrum.de

Sponsors and Collaborators

Herz-Zentrums Bad Krozingen

CryoCath Technologies Inc.

Boston Scientific Corporation

More Information

Responsible Party:	Herz-Zentrum Bad Krozingen ( Thomas Arentz )
Study ID Numbers:	CRYO-BAD-KROZ
Study First Received:	October 14, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00773539
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Herz-Zentrums Bad Krozingen:

atrial fibrillation
pulmonary veins
ablation

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009