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A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy (CRYO-RF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00773539
Recruitment Status : Unknown
Verified October 2008 by Herz-Zentrums Bad Krozingen.
Recruitment status was:  Recruiting
First Posted : October 16, 2008
Last Update Posted : October 16, 2008
Sponsor:
Collaborators:
CryoCath Technologies Inc.
Boston Scientific Corporation
Information provided by:
Herz-Zentrums Bad Krozingen

Tracking Information
First Submitted Date  ICMJE October 14, 2008
First Posted Date  ICMJE October 16, 2008
Last Update Posted Date October 16, 2008
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2008)
Parameters of inflammation and tissue damage, the time to achieve PV-Isolation, freedom from AF. [ Time Frame: before, during and 6 months after procedure ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
Official Title  ICMJE Safety and Efficacy of Transvenous Pulmonary Isolation for the Treatment of Atrial Fibrillation: A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation Ablation
Intervention  ICMJE
  • Procedure: PVI using an open irrigated tip catheter
    transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
  • Procedure: PVI using a closed irrigated tip catheter
    transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
  • Procedure: PVI using a cryoballoon
    transseptal PVI using the cryoballoon from CRYOCATH
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Procedure: PVI using an open irrigated tip catheter
  • Active Comparator: 2
    Intervention: Procedure: PVI using a closed irrigated tip catheter
  • Active Comparator: 3
    Intervention: Procedure: PVI using a cryoballoon
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2008)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2009
Estimated Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00773539
Other Study ID Numbers  ICMJE CRYO-BAD-KROZ
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thomas Arentz, Herz-Zentrum Bad Krozingen
Study Sponsor  ICMJE Herz-Zentrums Bad Krozingen
Collaborators  ICMJE
  • CryoCath Technologies Inc.
  • Boston Scientific Corporation
Investigators  ICMJE Not Provided
PRS Account Herz-Zentrums Bad Krozingen
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP