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

October 14, 2008 updated by: Herz-Zentrums Bad Krozingen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Procedure: PVI using a closed irrigated tip catheter
transseptal PVI using the CHILLI II catheter from BOSTON with confirmation of conduction block
Active Comparator: 1
Procedure: PVI using an open irrigated tip catheter
transseptal PVI using thermocooled ablation catheter (Biosense) with confirmation of conduction block
Active Comparator: 3
Procedure: PVI using a cryoballoon
transseptal PVI using the cryoballoon from CRYOCATH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
before, at the end of intervention, 6, 24 and 48 hours later.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herz-Zentrums Bad Krozingen

Collaborators

Boston Scientific Corporation
CryoCath Technologies Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

February 1, 2009

Study Completion (Anticipated)

August 1, 2009

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2008

Last Update Submitted That Met QC Criteria

October 14, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYO-BAD-KROZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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