Study cz-061120101626
Study Name
Randomized comparison of pulmonary vein isolation using RObotic and MAnual approach - ROMA study
Clinical Trial Registry Identifier
cz-061120101626
Study First Received
06.11.2010 16:26
Sponsor
Department of Cardiology, České Budějovice Hospital, Czech Republic
Principal Investigator
Alan Bulava
Information provided by
Alan Bulava
Purpose
Robotically assisted ablation represents a novel modality of pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). There is an assumption that better manoeuvrability and stability of the electromechanical robotic system might be translated to higher clinical success rate compared to manually driven ablation procedures. The study is designed and powered to prove at least 5% better clinical results of the robotic approach using Sensei Robotic Catheter System (Hansen Medical) compared to manually driven ablation.
Primary endpoints
Arrhythmia-free survival (comparison between groups MANUAL vs. ROBOTIC)
Secondary endpoints
Acute efficacy in pulmonary vein isolation, overall safety
Eligibility
Patients with paroxysmal atrial fibrillation undergoing first ablation procedure are eligible. Patients with dilated left atria (over 50 mm), significant valvular disease, significant ischemic heart disease, pregnat women and those unwilling to sign informed consent are excluded.
Contacts and Locations
Alan Bulava, email: alanbulava@seznam.cz, phone nu +420-387874389, Department of Cardiology, Ceske Budejovice Hospital, Czech Republic
More Information
None
Keywords
paroxysmal atrial fibrillation, robotic ablation, electromechanical robotic system, remote navigation
Status
Completed - data under evalution
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