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A Prospective Randomized Study Comparing Radiofrequency Energy With Cryoenergy

NCT00773539 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2008-10-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • CryoCath Technologies Inc.

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Herz-Zentrums Bad Krozingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-02-28
Completion
2009-08-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00773539 on ClinicalTrials.gov