About this trial
The goal of this clinical trial is to learn if an epicardial radiofrequency left atrial posterior wall isolation (box lesion ablation) prevents atrial fibrillation after cardiac surgery. The main question it aims to answer is:
\- Does box lesion ablation lower the number of patients experiencing de-novo atrial fibrillation requiring any treatment after cardiac surgery? Researchers will compare box lesion ablation to no ablation to see if ablation prevents postoperative atrial fibrillation.
Participants will undergo ablation or no ablation at the time of other cardiac surgery.
Data will be collected while in hospital. Additional information will be collected on 30th day after surgery by telephone call or during a visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients undergoing cardiac surgery by a single surgeon (V.K.)
Informed consent
Disqualifiers
History of atrial fibrillation/flutter
Minimally invasive approach
Off-pump surgery
Emergent/salvage surgery
Trial design
Parallel
Treatments tested in this trial
Radiofrequency ablation
DeviceIn this group of patients, epicardial radiofrequency left atrial posterior wall isolation will be performed with AtriCure Isolator Synergy OLL2 bipolar radiofrequency clamp without opening the left atrium.
Treatment groups
Trial outcomes
Primary outcomes
Postoperative Atrial Fibrillation
Incidence of clinically significant (requiring any type of intervention) postoperative atrial fibrillation
Secondary outcomes
Postoperative Mortality
All deaths occurring during the hospitalization in which the operation was performed, even if after 30 days; and all deaths occurring after discharge from the hospital, but before the end of the 30th postoperative day.
Postoperative Stroke
Number of patients who have a postoperative stroke (i.e., any confirmed neurological deficit of abrupt onset caused by a disturbance in blood supply to the brain) that did not resolve within 24 hours
Length of Stay
Postoperative length of in-hospital stay
Unplanned Readmission
Unplanned 30-day any cause readmission rate
Other outcomes
Operative time
Total operative time (min)
Cardiopulmonary bypass time
Total cardiopulmonary bypass time (min)
Cross-clamp time
Total cross-clamp time (min)
Other arrhythmias rate
Any arrhytmias other than POAF rate
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Vasily I. Kaleda
Lead sponsor
Yudin Hospital
Sponsor institution