Study cz-100220141204
Study Name
Zero-fluoroscopy approach to atrial fibrillation ablation using CARTO3 system and intracardiac echocardiography: a randomized study
Clinical Trial Registry Identifier
cz-100220141204
Study First Received
10.05.2013 12:04
Sponsor
Faculty of Health and Social Studies, University of South Bohemia in Ceske Budejovice (BOV 2012_001).
Principal Investigator
Alan Bulava
Information provided by
Alan Bulava
Purpose
To assess the feasibility, effectiveness and safety of zero-fluoroscopy RFA using intracardiac echocardiography and the CARTO3 mapping system with contact force measurement.
Primary endpoints
The primary endpoint of the study is acute efficacy, i.e. achievement of pulmonary vein isolation (or completeness of other linear ablation lines, if performed), and safety, i.e. absence of any procedure-related adverse events.
Secondary endpoints
None
Eligibility
All patients with paroxysmal atrial fibrillation who signed informed consent and fullfill subsequent criteria: no previous ablation, age 18-80 years, no significant valvular disease, pregnant women are excluded.
Contacts and Locations
Assoc. Prof. Alan Bulava, M.D., Ph.D., Department of Cardiology, Cardiovascular Centre, Ceske Budejovice Hospital, Czech Repubic, phone nu: +420-387874389, email: alanbulava@seznam.cz
More Information
Study was already finished. Results to be published in a peer-reviewed journal.
Keywords
atrial fibrillation; radiation; zero fluoroscopy; fluoroless; pulmonary vein isolation; intracardiac echocardiography; contact force; catheter ablation
Status
Completed - study under review
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