Study cz-060520121617
Study Name
Sequential hybrid procedure for persistent atrial fibrillation
Clinical Trial Registry Identifier
cz-060520121617
Study First Received
06.05.2012 16:17
Sponsor
Faculty of Health and Social Studies, University of South Bohemia, České Budějovice, Czech Republic
Principal Investigator
Alan Bulava
Information provided by
Alan Bulava
Purpose
To assess the results of staged hybrid procedure in patients with persistent and long-standing persistent atrial fibrillation combining endoscopic surgical radiofrequency ablation of the left atrium with the occlusion of left atrial appendage, followed by an electrophysiological diagnostic study and radiofrequency catheter ablation after a period of healing (staged-approach).
Primary endpoints
Arrhythmia-free survival. Comparison to literary data in patients with persistent or long-standing persistent atrial fibrillation.
Secondary endpoints
Efficacy of surgical procedure (pulmonary vein isolation, completeness of left atrial lines), safety of the endoscopic approach, overall safety of staged hybrid approach and occurrence of "postincisional" atrial tachycardias.
Eligibility
Patients with symptomatic drug refractory persistent or long-standing persistent atrial fibrillation willing to undergo hybrid treatment of the arrhythmia, while following a standardized protocol. All patients have to give the informed consent. The definition of long-standing persistent atrial fibrillation is based on recent guidelines. Selection criteria are: atrial fibrillation refractory to at least one class I or class III antiarrhythmic therapy, absence of coronary artery disease, absence of moderate or severe heart valve disease, absence of stroke, catheter ablation and thoracic surgery, and absence of thrombus in the left atrial appendage.
Contacts and Locations
Alan Bulava, Department of Cardiology, Budweis Hospital, Ceske Budejovice, Czech Republic; Ales Mokracek, Department of Cardiac Surgery, Budweis Hospital, Ceske Budejovice, Czech Republic email: alanbulava@seznam.cz, phone nu +420-387874389
More Information
Enrollment started after approval of the Intitutional Ethics Committee. The first patient was enrolled on 18th July 2012, the last patient was enrolled on 18thDecember 2015.
Keywords
atrial fibrillation, persistent, surgical treatment, radiofrequency ablation, hybrid procedure
Status
Enrolment completed
Protocol of the study published
Data being analyzed
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