A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

NCT00773539 | Unknown Phase 4 DMC

• 1 other identifier: CRYO-BAD-KROZ
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation Ablation

Keywords

atrial fibrillation; pulmonary veins; ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF.

  before, during and 6 months after procedure

Study Arms (3)

1

ACTIVE COMPARATOR

Procedure: PVI using an open irrigated tip catheter

2

ACTIVE COMPARATOR

Procedure: PVI using a closed irrigated tip catheter

3

ACTIVE COMPARATOR

Procedure: PVI using a cryoballoon

Interventions

PVI using an open irrigated tip catheter PROCEDURE

transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block

1

PVI using a closed irrigated tip catheter PROCEDURE

transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block

2

PVI using a cryoballoon PROCEDURE

transseptal PVI using the cryoballoon from CRYOCATH

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous Ablation or operation for AF
• Contra-indication for heart catheterisation
• Cardioversion for AF during the 2 weeks before the procedure

Sponsors & Collaborators

• Herz-Zentrums Bad Krozingen: lead
• CryoCath Technologies Inc.: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Herz-Zentrum

Bad Krozingen, 79189, Germany

RECRUITING

Related Publications (2)

• Jesel L, Arentz T, Herrera-Siklody C, Trenk D, Zobairi F, Abbas M, Weber R, Minners J, Toti F, Morel O. Do atrial differences in endothelial damage, leukocyte and platelet activation, or tissue factor activity contribute to chamber-specific thrombogenic status in patients with atrial fibrillation? J Cardiovasc Electrophysiol. 2014 Mar;25(3):266-70. doi: 10.1111/jce.12312. Epub 2013 Nov 22.

  PMID: 24172190 DERIVED

• Herrera Siklody C, Arentz T, Minners J, Jesel L, Stratz C, Valina CM, Weber R, Kalusche D, Toti F, Morel O, Trenk D. Cellular damage, platelet activation, and inflammatory response after pulmonary vein isolation: a randomized study comparing radiofrequency ablation with cryoablation. Heart Rhythm. 2012 Feb;9(2):189-96. doi: 10.1016/j.hrthm.2011.09.017. Epub 2011 Sep 13.

  PMID: 21920484 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas Arentz, MD

CONTACT

004976334020; thomas.arentz@herzzentrum.de

Dietmar Trenk

CONTACT

004976334020; dietmar.trenk@herzzentrum.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 14, 2008
• First Posted: October 16, 2008
• Study Start: July 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 16, 2008

Record last verified: 2008-10

Locations

DE (1)